National Lupus Outreach and Clinical Trial Education Program (Lupus Program) FUNDING OPPORTUNITY announcement: CPI-MP-17-002 ORC Orientation Training Webinar U.S. Department of Health and Human Services Office of the Secretary Office of Minority Health April 18, 2017 2pm Eastern Time

National Lupus Outreach and Clinical Trial Education Program AGENDA Review ORC Process OMH Mission Purpose of Grant: Lupus Project Requirements Summary of Funding Objective Review Criteria Questions and Answers .

Objective Review Committee: Guidance Function of Objective Review Committee (ORC): 1) Impartially evaluates the merit of applications against the criteria published in the program funding opportunity announcement (FOA); and 2) Evaluate the quality of each application against the criteria published in the FOA.

Objective Review Committee: Guidance Be familiar with the content within the FOA! Read each application assigned to you. Evaluate each application individually with the published FOA criteria only. Comment on strengths and weaknesses of each criterion per application. The first step in the actual review is to familiarize yourself with the funding opportunity announcement. The announcement will describe the program and list the evaluation criteria you must use when reviewing applications. These criteria are the ones published in the funding opportunity announcement and the ones on the review form you will complete. Read the applications you were assigned, keeping in mind the evaluation criteria. Complete a review form for each application, being careful to score the application only against criteria published in the funding opportunity announcement. Be careful not to compare any application with another; compare each application with the published criteria only. Comment on strengths and weaknesses of each criterion, and if you have general comments, note them under the “Other Relevant Comments” or “Recommendations” section on the review template in the ARM system. Also note whether the applicant has addressed any “Other Requirements” (e.g., Human Subjects, Paperwork Reduction, etc.) that may be included in the announcement. NOTE: Please be sure to document strengths and weaknesses for each criterion. The comments you make will not only be used in making decisions regarding which applications will be funded, but also are used in defending those decisions in cases of protests from unfunded applicants. Weaknesses are especially important for ratings less than “Outstanding.”

Objective Review Committee: Guidance ORC Summary Reports are Generated as a panel on the day of the review; Mailed to the applicant organization as feedback. Ad

Objective Review Committee: Guidance Conflict of Interest Signature affirms that you have no vested interest in any applicant organization If you discover you have a COI with an applicant, you must immediately notify your Grants Review Team. Recuse yourself during the entire discussion of that [COI] application. Other reviewers must not discuss the application with you. Prior to the panel review meeting, you will be asked to sign a Conflict of Interest form, affirming that you have no vested interest in any applicant organization. If during the panel meeting you discover you have a conflict with an applicant, you must notify your Objective Review Committee Chair and the Grants representative. You will not participate during the entire discussion of that application. Other reviewers must not discuss the application with you.

Objective Review Committee: Guidance The ORC’s review of the applications is confidential. Review materials and proceedings of the ORC are privileged information and are not to be revealed or discussed outside the ORC. The review of the applications is confidential; reviews must not be discussed outside the panel meeting. As mentioned at the beginning, a reminder that that review materials and proceedings of the objective review are privileged information and are not to be revealed or discussed outside the committee.

National Lupus Outreach and Clinical Trial Education Program Office of Minority Health (OMH) Mission Statement The mission of the office is to improve the health of racial and ethnic minority populations through development of policies and programs that will help eliminate health disparities. Purpose of Grant (FOA page 8): The Lupus Program aims to remove the barriers to diagnosis, treatment and disease management for minority populations impacted by lupus.

National Lupus Outreach and Clinical Trial Education Program Project Requirements (Page 11) OMH Expectations: Applicants have significant demonstrated expertise in: Having knowledge regarding lupus epidemiology, diagnosis, treatment and disparity related issues. Knowing the most effective strategies for achieving desired outcomes resulting from provider and paraprofessional education. Designing and testing provider and paraprofessional education model(s). Gaining access to representative samples of health care providers and paraprofessionals. Project Requirements (Page 11) Applicant Expertise: Having knowledge regarding lupus epidemiology, diagnosis, treatment and disparity related issues; Knowing the most effective strategies for achieving desired outcomes resulting from provider and paraprofessional education; Designing and testing provider and paraprofessional education model(s); Gaining access to representative samples of health care providers and paraprofessionals;

National Lupus Outreach and Clinical Trial Education Program OMH expects the National Lupus Outreach and Clinical Trial Education Program (Lupus Program) will accomplish the following two goals (FOA page 3) Priority A: Implement a national health education program on lupus Priority B: Develop, pilot and assess clinical trial education interventions for health care providers and paraprofessionals focusing on improving recruitment and retention rates in clinical trials for minority populations affected by lupus. OMH expects the National Lupus Outreach and Clinical Trial Education Program (Lupus Program) will accomplish the following two goals (FOA page 3) Priority A: Implement a national health education program on lupus. Priority B: Develop, pilot and assess clinical trial education interventions for health care providers and paraprofessionals focusing on improving recruitment and retention rates in clinical trials for minority populations affected by lupus.

National Lupus Outreach and Clinical Trial Education Program Project Requirements (FOA page 9) Priority A applications must propose projects with activities designed to target two to three Metropolitan Statistical Areas (MSAs) or other clearly identified geographic areas. Improve outreach and education efforts by PCPs and other health care providers and paraprofessionals in the target community(ies) to increase awareness and understanding of lupus and management of primary and secondary conditions related to lupus using culturally and linguistically appropriate materials and models; and Engage PCPs in improving lupus diagnosis and treatment in minority and/or disadvantaged populations. Project Requirements (FOA page 9) To increase awareness and understanding of lupus and management of primary and secondary conditions related to lupus using culturally land linguistically appropriate materials and models and; Engage Primary Care Providers (PCP)s in improving lupus diagnosis and treatment in minority and/or disadvantaged populations. Priority B applications must propose projects that will: Develop public-private and community partnerships to address minority populations participation in clinical trails; Design and test models for Primary Care Providers, other health care providers and paraprofessionals to assess attitudes, beliefs, and behavioral intentions associated with referral of minority populations to clinical trials;

National Lupus Outreach and Clinical Trial Education Program Project Requirements (FOA page 9) Priority B applications must propose projects that will engage three MSAs or other clearly identified geographic areas. Develop public-private and community partnerships to address minority populations participation in clinical trails; Design and test models for PCPs, other health care providers and paraprofessionals to assess attitudes, beliefs, and behavioral intentions associated with referral of minority populations to clinical trials; Applications focused on Priority B must propose projects that will: Develop public-private and community partnerships to address minority populations participation in clinical trails; Design and test models for PCPs, other health care providers and paraprofessionals to assess attitudes, beliefs, and behavioral intentions associated with referral of minority populations to clinical trials

National Lupus Outreach and Clinical Trial Education Program Project Requirements (FOA page 10) Priority B applications must propose projects that will (continued): Develop and test innovative model education programs; Implement educational interventions for PCP, other health care providers, and paraprofessional 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; Use experimental or quasi-experimental design in evaluating clinical trial education model(s) for PCPs, other health care providers and paraprofessionals; Project Requirements - Priority B (FOA page 10) 3. Develop and test innovative model education programs for Primary Care Providers, other health care providers and paraprofessionals serving minority populations; 4. Implement educational interventions for Primary Care Providers (PCPs), other health care providers, and paraprofessional using the selected model during the project period, and 5. Adapt the intervention(s) for clinical trial education to address lupus using a culturally and linguistically appropriate framework for minority populations; 6. Use experimental or quasi-experimental design in evaluating clinical trial education model(s) for Primary Care Providers (PCPs), other health care providers and paraprofessionals; 7. Design recruitment and participation initiatives for Primary Care Providers (PCPs) with the goal of increasing clinical trial participation and education among minority populations; 8. Develop and submit an action plan for disseminating a successful educational intervention, and 9. Prepare a manuscript for publication that reports the results of the educational intervention evaluation during the project period.

National Lupus Outreach and Clinical Trial Education Program Project Requirements (FOA page 10) Priority B applications must propose projects that will (continued): 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 educational intervention; and Prepare a manuscript for publication that reports the results of the educational intervention evaluation during the project period.

National Lupus Outreach and Clinical Trial Education Program Application Review Information Criteria (FOA pages 46 - 50) Factor 1 Executive Summary, Problem Statement and Organizational Capability 15 points Factor 2 Goals and Objectives, and Outcomes 10 points Factor 3 Program Plan including Proposed Intervention/Plan, Special Target Populations and Organizations, and Project Management 30 points Factor 4 Evaluation, Innovation and Dissemination Plan 40 points Factor 5 Budget 5 points The same evaluation criteria apply to applications under Priority A and under Priority B. Factor 1: Executive Summary, Problem Statement and Organizational Capability (15 points) -Reviewed on the quality and soundness of Executive Summary, Problem Statement and specific problem and/or issue(s) and the proposed intervention. -Knowledge of the problem and the target populations. -Capability to manage and evaluate the project Factor 2: Goals and Objectives (10 points) -The extent to which the goals and objectives are aligned to the Lupus program. -The extent to which the goals and objectives appear to be achievable in the stated time frame. Factor 3: Program Plan, Special Target Populations and Organizations and Project Management (30 points) -The quality and soundness of the logic and sequencing of the planned approach relative to the goals and objectives. -The strength of the qualifications, experience and appropriateness of the key staff. -The experience and knowledge of applicant and proposed partner organization with the National Standards for Culturally and Linguistically Appropriate Services in Health and Health care (National CLAS Standards) - The quality of the applicant’s description and documentation with data of demographic information on the targeted geographic areas, and the significance or prevalence of lupus among the target minority group (s). Factor 4: Evaluation and Dissemination Plan (40 points) -The quality and appropriateness of the applicant’s logic model. - The extent to which the proposed intervention represents an innovative or new approach that is expected to result in a substantial and significant improvement over current practices. -Improvements may be increased efficiencies (e.g. greater number of participants trained or served at low costs with the same significant outcomes) and/or an increased magnitude of change in knowledge, attitudes or practices. -The quality and soundness and clarity of the applicant’s plan and methodology to disseminate the projects results and findings. Factor 5: Budget (5 points) -The quality and completeness of the applicant’s Budget Narrative. - The degree to which the Budget Narrative defines the amount of work that is planned and expected to be performed and what it will cost and cost effectiveness. -

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 1: EXECUTIVE SUMMARY, PROBLEM STATEMENT AND ORGANIZATIONAL CAPABILITY (15 points): The quality and soundness of the description in the Executive Summary and Problem Statement of the proposed project and the nature and scope of the specific problem and/or issue(s) and proposed intervention. The depth and breadth of knowledge of the problem and the target populations demonstrated by the application. Applicant’s capability to manage and evaluate the project as determined by the applicant organization’s experience in managing similar project activities.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 1: EXECUTIVE SUMMARY, PROBLEM STATEMENT AND ORGANIZATIONAL CAPABILITY (15 points), continued: The extent and quality of the applicant’s experience providing services that are culturally and linguistically appropriate to the target population(s) as well as the extent of documented successful outcomes of past efforts and activities relative to providing services similar to those proposed to be provided under this funding opportunity. Applicant’s capability to manage the project as determined by the applicant organization’s experience in managing projects/activities, relative to the coordination of health and social services for individuals living with lupus and their families.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 2: GOALS, OBJECTIVES, and OUTCOMES (10 points): The extent to which project goals and objectives are aligned to the Lupus Program purpose and expectations and to the stated problems to be addressed. The merit of the goals and objectives. The extent to which the goals and objectives appear to be achievable in the stated time frame. The extent to which the objectives are specific, measurable, achievable, realistic and time-phased (SMART). The quality and nature of the proposed measurable outcomes. The extent of the expected impact on the target population of the proposed measurable outcomes.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 3: PROGRAM PLAN INCLUDING PROPOSED INTERVENTION/PLAN, SPECIAL TARGET POPULATIONS and ORGANIZATIONS, and PROJECT MANAGEMENT (30 points total): 3.1 Program Plan/Project Management (25 of 30 points) Appropriateness and merit of proposed approach in terms of methodology, creativity, and innovation relative to each objective The quality and soundness of the logic and sequencing of the planned approach relative to the goals and objectives. The strength of applicant’s capacity to carry out the plan. The strength of the qualifications, experience and appropriateness of proposed partner organizations.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 3: PROGRAM PLAN INCLUDING PROPOSED INTERVENTION/PLAN, SPECIAL TARGET POPULATIONS and ORGANIZATIONS, and PROJECT MANAGEMENT (30 points total): 3.1 Program Plan/Project Management, continued (25 of 30 points) The strength of the qualifications, experience and appropriateness of proposed key staff. The soundness of applicant’s organizational structure, inclusive of clearly defined roles and responsibilities. The strength of commitment of the applicant organization in terms of managerial and leadership support and staffing necessary to carry out proposed plan.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 3: PROGRAM PLAN INCLUDING PROPOSED INTERVENTION/PLAN, SPECIAL TARGET POPULATIONS and ORGANIZATIONS, and PROJECT MANAGEMENT (30 points total): 3.1 Program Plan/Project Management, continued (25 of 30 points) The experience and knowledge of applicant and proposed partner organizations with the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care (National CLAS Standards) (https://www.thinkculturalhealth.hhs.gov/Content/clas.asp) and the quality of the proposed project and ability of the applicant to implement the project in a culturally and linguistically manner tailored to the target population(s), including to Limited English Proficiency populations. Appropriateness of defined roles, responsibilities and lines of authority of and between the applicant, partner organizations, and proposed consultants. The quality and completeness of the signed Letter of Commitment between the applicant and its subrecipients/partners.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 3: PROGRAM PLAN INCLUDING PROPOSED INTERVENTION/PLAN, SPECIAL TARGET POPULATIONS and ORGANIZATIONS, and PROJECT MANAGEMENT (30 points total): 3.2 Special Target Populations (5 of 30 points) The quality of applicant’s description and documentation with data demographic information on the targeted geographic area, and the significance or prevalence of lupus among the target minority and/or disadvantaged group(s). Describe the group(s) targeted by the project (e.g., race/ethnicity, age, gender, educational level, income, and specific subpopulations) . The number of individuals the project expects to serve.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 4: EVALUATION, INNOVATION, AND DISSEMINATION PLAN (40 points total): 4.1 Evaluation (25 of 40 points) The quality and soundness of a clearly articulated and detailed plan for monitoring and evaluating progress toward desired results. Demonstration that the evaluation design will allow identification of significant program impact (i.e., design has sufficient power). The degree to which intended results are consistent with Lupus Program goals overall, and the stated objectives of the proposed project and activities.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 4: EVALUATION, INNOVATION, AND DISSEMINATION PLAN (40 points total): 4.1 Evaluation, continued (25 of 40 points) The quality and soundness of the applicant’s plan for tracking, assessing, and documenting progress toward achieving objectives, planned activities, and intended outcomes. The quality, soundness and clarity of the applicant’s plan for measuring Lupus Program outcomes and accomplishments. The quality and appropriateness of the applicant’s logic model. The quality and soundness of clearly articulated evaluation methods that are consistent with OMH evaluation guidelines.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 4: EVALUATION, INNOVATION, AND DISSEMINATION PLAN (40 points total): 4.2 Innovation (10 of 40 points) The extent to which the proposed intervention represents an innovative or new approach that is expected to result in a substantial and significant improvement over current practices. Improvements may be increased efficiencies (e.g., greater number of participants trained or served at lower cost with same significant outcomes) and/or increased magnitude of change in knowledge, attitudes or practices.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 4: EVALUATION, INNOVATION, AND DISSEMINATION PLAN (40 points total): 4.3 Dissemination (5 of 40 points) The quality, soundness and clarity of the applicant’s plan and methodology to disseminate the project’s results and findings in a timely manner and in easily understandable formats to the target audience, the general public, and other parties who might be interested in using the results of the project.

National Lupus Outreach and Clinical Trial Education Program Criteria for Factor 5: BUDGET (5 points): The quality and completeness of the applicant’s Budget Narrative. The degree to which the proposal demonstrate a clear and strong relationship between the stated objectives, project activities, and the budget. The degree to which the Budget Narrative defines the amount of work that is planned and expected to be performed and what it will cost with an explanation of how it will be cost effective.

National Lupus Outreach and Clinical Trial Education Program Award Information (FOA page 16) Funds Available: $2,000,000 Anticipated No. of Awards: Priority A up to 4 awards Priority B up to 2 awards Range of Awards Priority A: $250,000 - $325,000 Priority B: $450,000 - $550,000 Anticipated Start Date: 07/01/2017 Period of Performance: Not to exceed 1 year Budget Period Length: 12 months Type of Award: Grant

National Lupus Outreach and Clinical Trial Education Program (Lupus Program) FUNDING OPPORTUNITY announcement: CPI-MP-17-002 ORC ORIENTATION TRAINING WEBINAR U.S. Department of Health and Human Services Office of the Secretary Office of Minority Health April 18, 2017