MP-CPI-23-003_Lupus_NOFO_FAQs_FINAL_.pdf

FREQUENTLY ASKED QUESTIONS (FAQs)

National Lupus Outreach and Clinical Trial Education Program

Notice of Funding Opportunity # MP-CPI-23-003

A. ELIGIBILITY

1. What applicants are eligible and how will they be defined for this funding opportunity?

• 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.

Private non-profit institutions of higher education are eligible to apply.

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.

Examples of eligible Organizations include (NOFO pages 9-10):

• 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

#MP-CPI-23-003 Lupus NOFO FAQs

2. Can an individual apply for funding or For-Profit Entity apply for this opportunity?

• No. Eligible applicants are 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). Faith-based organizations and American Indian/Alaska

Native/Native American (AI/AN/NA) organizations are eligible to apply.

Please refer to page 13 of the NOFO for a list of example institutions.

3. Are eligible communities just those with high proportions of racial and ethnic minorities

(Consider revising this question)?

Is there a threshold that determines whether my community is eligible? (Recommend deleting this question)?

Who will decide-funding decisions (Keep this one)?

• All eligible entities that submit applications will advance through the screening process, and those with eligible applications, will advance to objective review. Your statement of need and the data you present to support it and other required elements (see E. APPLICATION REVIEW INFORMATION on pages 32-36) are vital in determining how well your application does in the merit review process.

• The Deputy Assistant Secretary for Minority Health will provide recommendations for funding to the Grants Management Officer to conduct risk analysis. In providing these recommendations, the Deputy Assistant Secretary for Minority Health will take into consideration the following additional factor:

• Equitable geographic distribution of projects.

• Grants and Acquisitions Management (GAM) Division will evaluate, in accordance with 45 C.F.R. § 75.205, each application recommended for funding by the program official indicated in Review and Selection Process for risks before issuing an award.

This evaluation may incorporate results of the evaluation of eligibility or the quality of an application. Upon completion of risk analysis and concurrence of the Grants Management Officer, OASH will issue Notices of Award. No award decision is final until a Notice of Award is issued. All award decisions, including the level of funding if an award is made, are final and you may not appeal.

3. Are For-Profit organizations eligible to participate in this funding opportunity?

a. No. Only public or private nonprofit entities (see NOFO page 9-10).

B. PREPARING TO APPLY

1. What is the deadline for submitting an application in response to this funding opportunity?

a. Applications are due August 1, 2023 by 6 p.m. Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time. (see NOFO page 27)

2. How can I stay up to date on any updates or changes to the notice of funding opportunity

(NOFO), additional information and resources, and other developments?

a. The best way to stay up to date is to subscribe to this NOFO on grants.gov. Please go to www.grants.gov and click the “Search Grants” tab in the upper left of the screen.

b. On the next screen, look for the “BASIC SEARCH CRITERIA” fields under SEARCH GRANTS header in the upper left corner. Enter “MP-CPI-23-004” in the Opportunity Number field and click the SEARCH button.

c. Click on the link under the Opportunity Number header. You will see a red “Subscribe” icon in the right corner. You then be prompted to either enter your username and password or establish one, after which you’ll be able to subscribe and get alerts.

3. Who should I contact if I still have questions about the NOFO? Questions about developing my application?

a. Who to contact will depend on the nature of your question? For programmatic questions, such as developing elements of your application, contact Paul Rodriguez at

Paul.Rodriguez@hhs.gov. Please CC: Duane Barlow on your email

b. Contact Duane Barlow at Duane.Barlow@hhs.gov for financial and grants-related questions. Please CC: Paul Rodriguez on your email (NOFO P. 47)

4. Who should I contact if I have issues with the grants.gov portal or the electronic application process?

Please contact Grants.gov Applicant Support:

Email: support@grants.gov

Telephone: 1-800-518-4726

(NOFO P. 47)

5. What registrations are needed to apply to this funding announcement?

a. Besides your registration at www.grants.gov, you will need a Dun and Bradstreet (D&B) Data

Universal Numbering System (DUNS) number to apply for a grant through www.grants.gov.

You will also need to register your organization with the System for Award Management

(SAM); please see page 27-28 of NOFO for more information.

b. A step-by-step description of the requirements for registering your organization to be able to apply for this and other funding announcements , along with the expected time for each mailto:support@grants.gov step, can be found here: https://www.grants.gov/web/grants/applicants/organization-registration.html

6. How do I register my organization on SAM.gov? What if my registration is expired?

a. Please refer to pages 27-28 of the NOFO. Your organization must register online in SAM

(https://www.sam.gov/SAM/). Grants.gov may reject submissions from applicants with nonexistent or expired SAM Registrations. A completed registration in SAM may be required prior to receiving any award based on your application.

b. Further helpful information and helpful tips are also available through the following quick start guide:

https://www.sam.gov/SAM/transcript/Quick_Guide_for_Grants_Registrations.pdf (PDF, 111 KB).

c. We recommend beginning your registration process immediately as delays in processing have been reported. Under normal operating conditions we recommend allowing at least up to 10 business days after you submit your registration for it to become active in SAM. This timeframe may be longer if SAM flags the information you provide for manual validation or there are delays in the required submission of a notarized letter by mail. You will receive an email alerting you when your registration is active.

7. Can you explain the page limits? What does or does not count for which limits?

a. 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).

b. 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).

Your project narrative is limited to 60 pages and does not include your Project Abstract

Summary. Since your project narrative plus appendices cannot exceed 50 pages, that leaves

20 pages for your appendices. The appendices should include the items described on pages

24-26 of the NOFO and listed here:

▪ Work Plan

▪ Logic Model

▪ Project Population(s) of Focus

▪ Memorandums of Agreement and/or Letters of Commitment

▪ Organizational Chart

▪ Curriculum Vitae/Resume for Key Project Personnel

▪ References Cited https://www.grants.gov/web/grants/applicants/organization-registration.html https://www.grants.gov/web/grants/applicants/organization-registration.html https://www.sam.gov/SAM/transcript/Quick_Guide_for_Grants_Registrations.pdf

c. You must submit these appendices as a single electronic file uploaded to the Attachments section of your Grants.gov application.

d. The SF-424, SF-424A, SF-424B, SF-LLL, Project Abstract Summary, and Budget Narrative

(including budget tables) do not count towards your 60 pages limit.

8. Are applicants required to submit memorandums of agreement (MOAs) and Letters of Commitment (LOCs)?

a. Refer to pages 24-26 in the NOFO. If available at the time of submission, signed MOAs or signed LOCs may be submitted for each partner (or one signed MOA with all partners) and include specific roles, responsibilities, resources, and contributions of partner(s) to the project.

b. If the applicant is unable to submit signed MOAs, the applicant may submit an unsigned MOA(s).

c. Fully executed MOAs and finalized tribal resolutions will be required following the issuance of any award made under this announcement if not received prior to award. If you are not providing these documents with your application, please indicate the anticipated date that you will have fully executed documents available for submission.

9. How can I get more information on this funding opportunity?

a. We strongly suggest that you register and attend the Technical Assistance webinar scheduled for June 27, 2023 from 4:30-5:45pm Eastern Time. To attend the webinar, please register at:

b. After you enter your information and click “Register,” you will get a confirmation email with details on how to join the webinar. There will be an opportunity to submit questions.

c. The webinar will be recorded for those unable to attend live. The recording will be posted to the OMH YouTube channel (https://www.youtube.com/user/OfficeMinorityHealth).

10. How can I stay up to date on any updates or changes to the notice of funding opportunity

(NOFO), additional information and resources, and other developments? (REPEAT #2-Delete)

a. The best way to stay up to date is to subscribe to this NOFO on grants.gov. Please go to www.grants.gov and click the “Search Grants” tab in the upper left of the screen.

b. On the next screen, look for the “BASIC SEARCH CRITERIA” fields under SEARCH GRANTS header in the upper left corner. Enter MP-CPI-23-003 in the Opportunity Number field and click the SEARCH button.

c. Click on the link under the Opportunity Number header. You will see a red “Subscribe” icon in the right corner. You will then be prompted to either enter your username and password or establish one, after which you will be able to subscribe and get alerts.

https://www.youtube.com/user/OfficeMinorityHealth http://www.grants.gov/

C. APPLICATION REVIEW

1. How will my application be reviewed?

a. Refer to pages 33-36 of the NOFO. An independent, objective review panel will assess all eligible applications according to criteria outlined in the notice of funding opportunity. In addition to the independent review, Federal staff will review each application for programmatic, budgetary, and grants management compliance. The Deputy Assistant Secretary for Minority Health provides recommendations for funding to the Grants Management Officer to conduct risk analysis. Upon completion of the risk analysis and concurrence of the Grants Management Officer, HHS/OASH issues Notices of Award.

2. Are budgets scored as part of the review process?

a. Budgets will not be scored by objective review committees, but they may comment on the appropriateness of the budget, like for example, if too much or too little is budgeted for a corresponding activity. Federal staff will review budgets for compliance with regulatory requirements.

3. Who makes the final funding decisions? Can we appeal if we are not selected?

a. The Deputy Assistant Secretary for Minority Health makes the final funding recommendations, based on the results of objective reviews [Equitable geographic distribution of projects and taking into account the criteria specified in the NOFO on pages

40-46]. The funding decisions are final and cannot be appealed.

D. PROGRAM EXPECTATIONS

1. Tish, your presentation covered program expectations including the Disparity Impact

Statement. Tish are applicants required to submit Disparity Impact Statement or DIS with their competitive application?

• RESPONSE – No, applicants are not expected to submit Disparity Impact Statement or

DIS with the competitive application. Successful applicants or Recipients will submit

DIS 30-days after the start of the budget period.

2. What is the Disparity Impact Statement (DIS) expectation? What is the purpose of the DIS?

• The DIS is an expectation of the recipient for the OMH program. The DIS uses local data, whenever possible, to identify racial and ethnic minority populations at highest risk for health disparities relevant to this initiative. The DIS will provide the contextual and measurement framework for ongoing monitoring and determining the impact of the project activities on outcomes and the overarching goal of advancing health equity.

• Developing and implementing a disparity impact statement will help the project to:

• Strategically focus on tracking disparities in access, use and outcomes for racial, ethnic minority subpopulations,

• Use program performance data to implement a QI process, and

• Leverage the National Culturally and Linguistically Appropriate Services (CLAS)

Standards as part of the QI process to ensure better access, use and outcomes for the identified disparate population(s).

3. Are there required partnerships for this program?

• Yes. The applicant should involve at least two partners (including the applicant), one of which must be a:

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

• National, state or local professional organization that represents primary care physicians, other health care providers, and/or community health workers (CHWs)

• Tribe or tribal organization

4. Can the project develop new patient and provider resources to achieve expected outcomes?

• OMH expects recipients to use and disseminate the resources developed as a result of previous OMH-supported lupus programs and projects to achieve expected program outcomes. A list of resources from OMH supported lupus programs dating back to 2009 is provided in the NOFO.

5. Can we use resources that were not developed under OMH-supported programs and projects?

• Resources that were not developed from OMH-supported programs and projects can be used under the Lupus program. Justification for use and evidence of effectiveness should be provided for resources developed outside of OMH-supported programs and projects.

6. Can the project use the grant funding to develop new interventions to increase minority participation in Lupus clinical trials?

• OMH recognizes that numerous interventions currently exist to support participation in clinical trials, some of which were developed under previous OMH supported programs.

• As outlined in the NOFO page 7, OMH encourages 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.

https://thinkculturalhealth.hhs.gov/

7. Is it acceptable for an application to focus on any rheumatic disease?

• No. The Lupus Program seeks to reduce lupus-related health disparities among racial and ethnic minority populations disproportionately affected by this disease. OMH expects the Lupus Program to result in the identification of effective interventions that increase racial and ethnic minority enrollment and retention in lupus clinical trials.

8. Why should community health workers be considered as a workforce to include in intervention models?

• Literature shows, that clinical trials that use recruitment and retention strategies that involve CHWs have increased enrollment of racial and ethnic minority populations and decreased refusal by minority populations. OMH has supported the use of “partnership-based interventions” in other programs that include CHWs and promotores de salud, who provide education and connect patients to services by helping them overcome barriers in their communities and health systems. CHWs often come from the minority communities they serve and are able to provide culturally and linguistically responsive services.

9. What types of interventions should be considered by projects to tailor and implement?

• Interventions may include:

• Provider 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 for CHWs to increase racial and ethnic minority enrollment and retention in lupus clinical trials

• Lupus clinical trial education models for minority populations

10. What is the period of performance for the award?

• In the NOFO, pages 8-9, state that funds are awarded in annual increments and generally for a period of performance up to 2 year(s), although we may approve shorter periods of performance. In the Award Information table in the NOFO, states that the estimated period of performance will not exceed 3 year(s).