IR-ORI-25-003 Program Development and Evaluation Program.pdf

U.S. Department of Health and Human Services

Office of Research Integrity

Notice of Funding Opportunity Ensuring Research Integrity - Program Development and Evaluation Program (PDE)

Opportunity Number

IR-ORI-25-003

Application Due Date 07/30/2025 at 6:00 PM Eastern

Technical Assistance Webinar Date 07/15/2025 at 1:00 PM Eastern

BASIC INFORMATION

Opportunity Title Ensuring Research Integrity - Program Development and Evaluation Program (PDE)

Program Office Office of Research Integrity Application Submission and Format

Electronic application submitted via Grants.gov ONLY. Opportunity Number

IR-ORI-25-003

Award Type

G (Grant) Application Deadline

07/30/2025 06:00 PM Eastern Announcement Type

Initial Technical Assistance Webinar Date

07/15/2025 01:00 PM Eastern

Assistance Listing 93.085

Technical Assistance Webinar Details https://www.ori.hhs.gov Eligible Applicants (see Section A.1 for full details)

Executive Order 12372 does not apply to this NOFO (see section E.3.D)

Estimated Total Funding Available $150,000

Estimated Period of Performance (months)

Estimated Number of Awards

Anticipated Award Date

09/15/2025 Anticipated Award Funding Range $50,000 to $75,000 per budget period

Anticipated Project Start Date 09/30/2025

QUESTIONS?

OASH_Grants@hhs.gov

Additional contact information in Section G mailto:OASH_Grants@hhs.gov

SUMMARY

The Office of Research Integrity announces the opportunity to apply for Fiscal Year (FY) 2025 awards under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

The Program Evaluation and Development Program was started by ORI in 2020. The purpose of the grant program is to support projects for the development and implementation of innovative approaches and tools to promote research integrity and prevent misconduct. This includes creating interventions based on empirical evidence, including findings from ORI-funded research, and tools to identify at-risk individuals or laboratories. We seek applications for projects that create and/or evaluate interventions and assessment tools aimed at promoting research integrity. We anticipate two awards of between $50,000 and $75,000 in total costs

The Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management Division (GAM) will administer this competition.

We encourage you to review all program requirements, eligibility information, application format and submission instructions, and other content of this notice to ensure your application complies with all requirements.

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

a. Eligible Entities

Universities, hospitals, laboratories, other public or private institutions, and individuals are eligible to apply for an award under this announcement.

Faith-based organizations and community-based organizations are eligible to apply.

American Indian, Alaska Native, Native Hawaiian, and Pacific Islander organizations are eligible to apply.

Additional examples of eligible entities include:

• State governments

• County governments

• City or township governments

• Special district governments

• Independent school districts

• Public and State controlled institutions of higher education

• Native American tribal governments (Federally recognized)

• Public housing authorities/Indian housing authorities

• Native American tribal organizations (other than Federally recognized tribal governments)

• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

• Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education

• Private institutions of higher education

• Individuals

• For profit organizations other than small businesses

• Small businesses

b. PD/PI Eligibility

There is no restriction on an individual’s eligibility to be Project Director (PD)/Principal Investigator (PI) on an application. However, we will not make an award with a PD/PI who has an active government-wide exclusion, suspension, or debarment recorded in SAM.gov.

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

c. Other Considerations Submitting Multiple Applications

1. Eligible Applicants

A. ELIGIBILITY INFORMATION

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

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

Submitting an Application as a Group or Consortium

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

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

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

We will conduct a risk assessment on the applying entity (Section F.4) prior to making any award.

Direct and Indirect Costs

Direct and indirect costs proposed and, if successful, must meet the cost requirements of 45 C.F.R. part 75 Subpart E—Cost Principles (“Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards” or UAR). These requirements apply to you and any subrecipients. You should thoroughly review these regulations before developing your proposed budget. We have provided an excerpt of the more commonly used cost categories in Section J; however, you should review the full Cost Principles.

Restrictions on Costs

Restrictions on costs appear in Section D.2.c.2. Such costs are unallowable for awards made under this NOFO.

We may not disqualify your application from merit review if it contains a request for restricted costs. In some cases where those costs are not essential to the success of the project, we may negotiate with you for modifications to the project implementation or budget prior to making an award. However, if your application relies substantially on restricted costs, we may decide to not fund your application because any negotiated changes would fundamentally change the project as proposed.

Eligibility Documentation

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

https://www.ecfr.gov/current/title-45/part-75/subpart-E https://www.ecfr.gov/current/title-45/part-75/subpart-E

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

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

Application Disqualification

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

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

2. Application Responsiveness Criteria We will review your application to determine whether it meets the responsiveness criteria in Section F.1. If your application does not meet the responsiveness criteria, we will disqualify it from the competition; we will not review it beyond the initial screening.

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

If you voluntarily include cost sharing in your application, you must include in your budget narrative a non-federal sources justification as described in Section J.4 or we will disqualify your application (Section F.1.b). Voluntary cost sharing is not expected for research applications.

During merit review (Section F.3), reviewers will only consider cost sharing in the overall assessment of the adequacy of the total proposed budget (i.e., Federal share plus cost share) to support your proposed project. You will not receive any preference, priority, or special consideration for voluntarily including cost sharing or matching in your proposed budget.

If you propose any voluntary cost sharing or matching in your budget package, we will include that voluntary cost sharing or matching as a commitment on the notice of award at the level you proposed (Section D.2.c). Any later change in the cost sharing or matching commitment will require prior approval of the grants management officer.

Cost- sharing or matching may include any in-kind contributions necessary for the implementation of the proposed project (45 C.F.R. § 75.306).

https://www.ecfr.gov/current/title-45/section-75.306

B. PROGRAM DESCRIPTION

The Office of Research Integrity anticipates making award(s) for Fiscal Year (FY) 2025 under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

Institutions applying for or receiving Public Health Service (PHS) support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training are required to “[f]oster a research environment that promotes research integrity and the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.” 42 C.F.R. § 93.300(c). Core to ORI’s mission is the support of education and outreach activities that aid PHS-funded research institutions in their efforts “to teach the responsible conduct of research, promote research integrity, prevent research misconduct, and… respond effectively to allegations of research misconduct.” (65 Fed. Reg. 30,600, 30,601 (May 12, 2000)).

This notice solicits applications for projects to develop and implement programs and tools related to the prevention of research misconduct, protection of whistleblowers, and the furtherance of research integrity in the United States.

1. Purpose of this Opportunity

a. Background

The purpose of this announcement is to promote the development and implementation of innovative programs and tools for (a) fostering research integrity; (b) preventing or detecting research misconduct; (c) protecting whistleblowers, respondents, and other vulnerable researchers; and (d) enabling the proper handling of research misconduct allegations. For the purposes of this announcement, research integrity is defined as the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms of the research community.

ORI has funded grant projects over the years with the goal of providing evidence based empirical research to aid researchers in creating programs and tools that promote research integrity and prevent research misconduct. With this development, there is a growing need for programs to evaluate the effectiveness of existing programs and a need to develop new, innovative programs or tools that meets today’s challenges. This funding opportunity specifically aims to support the development and evaluation of programs and research tools that promote research integrity and cultivate norms, values, and cultures that promote the appropriate practice of science, prevent and detect research misconduct, protect whistleblowers, respondents and other vulnerable populations, and enable the proper handling of research misconduct allegations.

ORI encourages proposed projects to include collaboration or consultation with institutional research misconduct officials, professional organizations, and/or others who have direct experience with 42 C.F.R. Part 93, including institutional attorneys experienced with institutional research misconduct proceedings. ORI also encourages proposed projects take place in research settings and/or include individuals actively engaged in or training for careers in research.

b. Opportunity Details

Priorities for this Opportunity

This program supports the creation and evaluation of interventions and assessment tools aimed at promoting research integrity. Projects may include:

1. Development of Educational Resources:

o Creation of novel online training modules incorporating interactive scenarios to teach principles of research integrity.

o Development of engaging, in-person or classroom educational programs that promote the responsible conduct of research, prevent research misconduct, or encourages the reporting of suspected research misconduct.

2. Creation of Risk Assessment Tools:

o Design, develop, and test assessment tools for principal investigators, department chairs, or other research administrators to evaluate the risk for individuals, laboratories, or research programs to engage in misconduct or detrimental research practices.

o Design, develop, and test assessment tool that examines institutional research culture or practices that impact or lead to potential research misconduct.

3. Implementation and Testing of Intervention Programs:

o Pilot interventions designed to improve data management and record-keeping in labs, with pre- and post-assessment of research integrity.

o Implementation of mentorship and leadership training programs in research settings to foster a culture of ethical and responsible research.

Goals and Objectives for this Opportunity Goals for this opportunity include:

• Design and test interventions aimed at enhancing research integrity.

• Develop assessments to identify the risk of misconduct or detrimental research practices.

• Evaluate the effectiveness of these programs or tools in various research environments.

The intended effect will be measured by the publication of relevant research findings and/ or the development of novel practical approaches, resources, training materials, or tools that can be used by researchers, research administrators, and research institutions to promote research integrity

Expected Performance Goals and Outcomes for Funded Projects

Award recipients under this announcement should meet the below expectations in the execution of their funded project:

A. Design and test interventions aimed at enhancing research integrity.

We expect that the recipient will conduct research focused on developing and implementing innovative programs and tools to promote research integrity and prevent misconduct.

B. Demonstrate the impact and/or effectiveness of the policies and training:

We expect the recipient to evaluate existing policies and training materials to assess their impact.

We expect that recipients will revise the materials as necessary to address issues, identified during the evaluation process, that may prevent effective implementation by the relevant stakeholders.

C. Creation of Risk Assessment Tools:

We expect the recipient to design, develop, and test assessment tools for principal investigators, department chairs, or other research administrators to evaluate the risk for individuals, laboratories, or research programs to engage in misconduct or detrimental research practices.

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

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

C. AWARD INFORMATION

We intend to make funds available for competing G (Grant) awards.

Budget period(s)

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

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

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

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

• Full Text of the NOFO

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

• Sample templates, if available.

In addition to the four standard forms in the application package, your application will consist of 3 sections of materials you prepare:

1. Project Narrative;

2. Appendices to the Project Narrative; and

3. Budget Package.

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

a. Project Narrative – Formatting

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

Format of the Application

D. APPLICATION CONTENTS AND FORMAT

Names of Individuals

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

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

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

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

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

If you receive an award, a request for a change in PD/PI or key personnel under any circumstance requires prior approval of the grants management officer before becoming effective. We may disallow any costs incurred as a result of that change prior to our approval. See Section H.1.c.

Page Formatting

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

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

Use a 12-point font.

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

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

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

You must submit your application in the English language and in terms of U.S. dollars (45 C.F.R. § 75.111(a)).

https://www.ecfr.gov/current/title-45/section-75.111

Page Limits

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

The page limits do not include the budget package (Section D.2.c)

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

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

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

Do not hyperlink to documents or sites outside of your application to augment your application. Reviewers will not be permitted to follow links to external content during their assessment of your application. The one exception to this is a link to your internal controls as part of your budget package (Section D.2.c.3).

Page Limit

Project Narrative 25

Project Narrative plus Appendices

Labeling Proprietary Information

Proprietary information includes patentable ideas, trade secrets, privileged or confidential commercial or financial information, the disclosure of which may harm the applicant.

You should include proprietary information in your application only to the extent that it is essential to the reviewers’ understanding of the project. Proprietary information should not appear in your Project Abstract Summary.

If your application contains proprietary information, you should clearly label the top of the first page of the project narrative. For example, Contains proprietary or confidential information that [Your Organization Name] requests not be released to persons outside the government, except for purposes of review and evaluation.

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

b. Appendices to the Project Narrative – Formatting

Your appendices should include any specific items outlined in Section D.2.b. Your documents should be easy to read.

You should use the same formatting specified for the Project Narrative. However, documents such as résumés/curricula vitae/biographical sketches, organizational charts, tables, Memoranda of Agreement (MOAs) or Letters of Commitment (LOCs) may have formatting common to those documents, so long as the pages are easy to read. For example, resumes, MOAs and LOCs may be single-spaced.

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

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

c. Budget Package - Formatting The budget narrative should use the formatting required of the project narrative for the explanatory text. Budget tables may be single-spaced but should be laid out in an easily readable format and within the printable margins of an 8.5” x 11” page. You must use an acceptable file format (Section E.3.a). We do not accept Excel or other similar spreadsheet formats.

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

We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested; third column, non-federal resources; and last column, total budget.

Object Class Federal Funds Requested

Non-Federal Resources Total Budget

Personnel $100,000 $25,000 $125,000

2. Content

a. Project Narrative - Content

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

Successful applications will contain the following:

1. Project Description

You should:

• Describe the proposed project and how it will address the Expectations of this announcement. You should:

o Identify the focus area(s) being addressed by the proposed project.

o Explain the rationale for the proposed project.

o Describe the scope and breadth of the issue and critical barrier(s) to progress on the selected research integrity topic/focus area. Describe potential impacts on affected groups or populations (e.g., researchers, research administrators, Research Integrity Officers).

o Describe in detail how the project will potentially affect the populations served, specific subgroups within those populations, and other interested stakeholders as identified.

o State concisely the goals of the proposed project and summarize the expected outcome(s), including the impact that the results of the proposed project will exert on the selected topic/focus area (e.g., solve a specific problem, provision of a new resource).

o Describe the overall strategy, activities (e.g., research, material development, implementation, and evaluation efforts), and methods that you will use to accomplish the goals of the project. Include how the data will be collected, analyzed, and interpreted.

o Describe why the specific activities were selected. Explain how the proposed activities will help to achieve the overall project goals and outcomes. Indicate why the overall approach as described is appropriate. Present a clear connection between selected research integrity topic/focus area and the proposed activities.

o Describe any novel approaches or methods you intend to employ to achieve the project goals. If utilizing approaches or methods that do not diverge substantially from existing practices, describe the novelty in the application of those methods to the topic. Reference, where applicable, existing approaches for the purpose of contrasting the novel approaches or methods you propose.

o List succinctly the specific and time-framed objectives of the proposed project as they relate to the project goals.

o Provide detailed descriptions of specific materials proposed for development or modification.

o List succinctly the anticipated, specific, and measurable outcomes of the proposed project as they relate to the project goals.

o Discuss potential problems, alternative strategies, and benchmarks for success with respect to project goals. Note any major barriers you expect to encounter as well as how your project will be able to overcome those barriers.

• Describe how technology will be incorporated to advance programs and services, provide training and/or technical assistance, and disseminate information and products.

• Describe the role and makeup of potential individuals or entities intended to be involved in completing specific tasks. Identify the level of effort each is anticipated to provide in completing programmatic activities. Describe how each will engage in the project.

• If the project is in the early stages of development, describe any strategies that you will use to establish feasibility, and address the management of any high-risk aspects of the proposed work.

• If applicable, describe and justify the proposed involvement of human subjects (45 C.F.R.

Part 46) in the proposed work by describing the following:

o Characteristics of the subject population, including their anticipated number, age range, etc.

o The sampling plan and justification for proposed plan as well as the recruitment and retention strategies and the criteria for inclusion or exclusion of any subpopulation.

o Data that will be collected from human subjects for the project(s) described in the application.

o Who will have access to individually identifiable private information about human subjects.

o How the records and/or data will be collected, managed, and protected as well as whether material or data that include individually identifiable private information will be collected specifically for the proposed research project.

o Plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent.

o Identify the Institutional Review Board (IRB) you will use during the study, including the Federal-wide Assurance number and IRB registration number.

Include a proposed timeline for acquiring the approval of the IRB for the proposed activities. Any award based on your application does not supersede the need for IRB review, approval, or determination of an exemption. Do not include in your application the package prepared for your IRB review.

2. Outcomes

You should:

• Keep the focus of this section on describing what outcome(s) will be produced by the project. In many cases, it is very appropriate for a project to have only ONE outcome that it is trying to achieve through the intervention reflected in the project’s design. You should use the Evaluation section noted below to describe how you will assess the project outcome(s).

• Specify the tangible/measurable outcome(s) that will result from your project.

HHS/OASH will not fund any project that does not include measurable outcomes. A tangible/measurable outcome is an observable end-result that describes how an activity, event, resource, or approach helps the intended audience; it is large enough to be noticed.

It demonstrates the “impact” of the activity, event, resource, or approach. For example, a tangible/measurable outcome may be a change in knowledge, skill, attitude, awareness, or behavior about the subject matter because of the project. This may include new knowledge or a tangible/measurable increase in institutional awareness. A tangible/measurable outcome is not a measurable/quantifiable “output,” such as the number of materials produced, the number of stakeholders using these materials, or the number of lectures/training sessions provided. These numbers in combination with other measures may contribute to the overall evaluation of the activity or project.

• In addition to any discussion in the Project Description, describe how you envision the project will benefit the field at large. In addition to any discussion in the Dissemination section below, describe how you will report on the outcomes of the project.

3. Evaluation

You should:

• Describe the quantitative and/or qualitative tools and techniques that you will employ to assess and evaluate the ease with which the materials developed as part of this project can be directly used by the relevant stakeholder(s), their effectiveness in facilitating improved practices, and their impact on research integrity and/or compliance with 42 C.F.R. Part 93.

• Describe the quantitative and/or qualitative tools and techniques that you will employ to assess and evaluate outcome(s) and how you will identify and document the “lessons learned.”

• Describe how you will collect and report evaluation data. Describe how you will ensure the validity and reliability of these data.

3. Dissemination You should:

• Describe a comprehensive, time-framed dissemination plan to communicate key findings to stakeholders, the public, and/or others who might be interested in the results of the proposed project. HHS/OASH expects that nationwide dissemination of products and knowledge will be facilitated.

• Describe the method you will use to disseminate the project’s results and findings in a timely manner and in easily understandable formats to the PHS-funded research community, the public, and/or others who might be interested in using the results of the project to inform practice, service delivery, program development, and/or policymaking.

4. Project Management You should:

• Identify the Principal Investigator, collaborators, and other researchers, including subrecipients, consultants, or contractors, proposed for the project. Include a clear delineation of the roles and responsibilities of each, their relevant expertise, and how they will contribute to achieving the project goals and outcomes.

• Identify the individual who will serve as the Principal Investigator/Project Director and that individual’s qualifications. HHS/OASH expects that, throughout the award period, the Principal Investigator/Project Director will be involved in, and have substantial knowledge about, all aspects of the project.

• Specify who would have day-to-day responsibility for key tasks such as: leadership of project; monitoring the project’s on-going progress; preparation of reports; and communications with collaborators and HHS/OASH.

• Describe the approach that you will use to monitor and track progress on the project’s tasks and objectives.

5. Environment and Organizational Capability You should:

• Describe your organization’s capability to successfully implement the proposed project.

• Describe the research/scientific environment in which the work will be done and how it will contribute to the probability of success. This should include a description of the institutional support, equipment, and other physical resources available to the investigators.

• Describe how your organization (or the division of a larger organization which will have responsibility for this project) is organized, the nature and scope of its work, and the capabilities it possesses.

• Describe the organizational investment in the success of the investigator and proposed project. Examples of such investment include provision of resources such as office space sufficient for project needs, logistical support such as administrative management and oversight, and financial support such as protected time for research with salary support.

• Describe the activities the organization undertakes to “[f]oster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct” (42 C.F.R. § 93.300(c)).

Describe the way in which the proposed project will contribute to and enhance the recipient’s (institution’s) activities related to research integrity and/or compliance with 42 C.F.R. Part 93.

• Describe the capabilities of your organization not included elsewhere 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. If appropriate, include an organization chart in your Appendices showing the relationship of the project to the current organization.

• 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.

Describe collaborations in the application and accompanying letters of commitment.

b. Appendices to the Project Narrative – Content All items described in this section will count toward the total page limit of your application. You must submit them as a single electronic file uploaded to the Attachments section of your Grants.gov application.

Samples and optional forms/templates for some of these items are located under the Related Documents tab for this NOFO on Grants.gov.

Your application should include the following appendices:

c. Budget Package – Content A complete budget package consists of the following required components:

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

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

• Plan for oversight of federal funds.

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

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

1. Standard Form SF-424A

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

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

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

Do not include costs beyond the first budget period in the object class budget in box 6 of SF- 424A or box 18 of SF-424. The amounts entered in these sections should only reflect the first budget period.

If there is a discrepancy between your SF-424A and budget narrative and justification, we will rely on the narrative and justification to determine the final amounts.

2. Budget Narrative With Justification

Your budget narrative must include a detailed line-item budget and must include calculations for all costs and activities by the “object class categories” identified on SF-424A. You must provide a detailed justification for the costs by object class. The object class budget organizes your proposed costs into a set of defined categories.

Use the guidelines in Section J.4 for preparing the detailed object class budget.

Budget Periods

Your budget narrative must describe the first budget period in detail. For each proposed cost for the first budget period, provide a justification that includes explanatory text and line-item detail.

You should describe how you derived your categorical costs. Your justification should show the necessity and reasonableness of the proposed costs for the project.

For subsequent budget years in an anticipated multi-year period of performance, provide a summary narrative and line-item budget for each year beyond the first. For categories or items that differ significantly from the first budget period, provide a detailed justification explaining these changes.

Funding levels for all approved budget periods after the first are generally the same as the initial award amount and are subject to an offset with funds unused in the previous budget period.

Carryover of unobligated funds from one budget period to the next requires prior approval.

Determining Proposed Costs

Your budget narrative should justify the overall cost of the project as well as the proposed cost per activity, service delivered, and/or product. For example, the budget narrative should define the amount of work you have planned and expect to perform, what it will cost, and an explanation of how the result is cost effective. If you are proposing to provide services to clients, you should describe how many clients you expect to serve, the unit cost of serving each client, and how this is cost effective.

Proposed costs must adhere to the cost principles described in 45 C.F.R. §§75.400-75.477. We have provided additional information on the most common cost categories for applications for OASH awards in Section J.4.

Budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. Carefully review Funding Restrictions (below) for specific information regarding allowable, unallowable, and restricted costs.

Describing Federal and Non-federal Share

Both federal and non-federal resources (if applicable) must be detailed and justified in the budget narrative. “Federal resources” refers only to the HHS/OASH funds for which you are applying under this NOFO. “Non-federal resources” are all other non-HHS/OASH federal and non-federal resources.

If matching or cost sharing is required or offered voluntarily, you must include a detailed listing of any funding sources identified in box 18 of SF-424 (Application for Federal Assistance).

Selecting an Indirect Cost Method

You must state the method you are selecting for your indirect cost rate. See Indirect Costs (Section J.4) for further information about the methods.

If you are providing in-kind contributions of any type or value, including costs otherwise covered by your indirect cost rate, you must identify those costs, and you should, as appropriate, include the value of the in-kind contribution as proposed cost-sharing (voluntary or required) (45 C.F.R. § 75.306).

If you are using a negotiated indirect cost rate, you may submit a copy of your negotiated agreement with your budget narrative. We may require a copy of your agreement prior to making any award to you.

Subrecipient and consultant activities must be described in sufficient detail to describe accurately the project activities that each will conduct.

All subrecipient and consultant detailed costs should be included on their respective line items and not broken out in the overall project object class line items. For example, contractor travel should be included in the Contractual line item not in Travel. See Section J.4 for more information.

Funding Restrictions https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-E https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.306 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.306

The following restrictions apply to costs you may propose and be awarded.

Indirect costs for training

Indirect costs for training are limited to a fixed rate of eight percent of the modified total direct costs (MTDC) exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000 (45 C.F.R. § 75.414 (c)(1)(i)).

Pre-Award Costs

Pre-award costs are NOT allowed. Pre-award costs (45 C.F.R. § 75.458) are those incurred prior to the effective date of the Federal award directly pursuant to the negotiation and in anticipation of the Federal award where such costs are necessary for efficient and timely performance of the scope of work.

Salary Rate Limitation

Each year’s appropriations act limits the salary rate that you may charge to the grants and cooperative agreements that we award. You must not use award funds to pay the salary of an individual at a rate in excess of Federal Executive Pay Scale Executive Level II.

As of January 2025, the Executive Level II salary is $225,700. This amount reflects an individual’s base salary exclusive of fringe benefits and any income that an individual working on the award project may be permitted to earn outside of the duties to the applicant organization. This salary rate limitation also applies to subawards/subcontracts under an HHS/OASH award.

An example of the application of this limitation for an individual devoting 50% of their time to this award is broken down below:

Salary Rate Limitation

Individual’s actual base full-time salary $350,000 with 50% of time devoted to project, i.e., 0.5 FTE

Direct salary ($350,000 x 0.5) = $175,000

Fringe (25% of salary) = $43,750

Total = $218,750

Individual’s base full-time salary adjusted to Executive Level II:

$225,700 with 50% of time devoted to the project

Direct salary ($225,700 x 0.5) = $112,850

Fringe (25% of salary) = $28,121.50

Total amount allowed = $141,062.50 https://www.ecfr.gov/current/title-45/section-75.458

Appropriate salary rate limits will apply as required by law.

Vehicle Purchase

We will not approve a vehicle purchase at the time of award even when included in your application. You must obtain prior approval before the purchase of a mobile health unit or any other vehicle with award funds. A request for prior approval must include a detailed justification of the need for the vehicle that includes an analysis of comparing purchase, lease, and other alternatives. Equipment purchases are subject to transfer to another federal project or sale at the end of the period of performance (2 C.F.R. § 200.313(e)).

Construction Costs

We will not approve construction costs. This includes major improvements to or significant renovations of facilities.

Medical Services Costs

Costs of medical services are NOT allowed under this funding opportunity.

Medical services are clinical services provided in an outpatient clinic and or inpatient hospital setting by a licensed practitioner. In contrast, non-medical social and support services include community-based strategies that address social determinants of health (SDOH). Trained individuals, such as community health workers (CHWs) or promotores/as de salud provide non-medical social and support services.

3. Plan for Recipient Oversight of Federal Award Funds

You must include a plan for oversight of federal award funds which describes:

• how your organization will provide oversight of federal funds and how award activities and partner(s) will adhere to applicable federal award and programmatic regulations.

Include identification of risks specific to your project as proposed and how your oversight plan addresses these risks.

• the organizational systems that demonstrate effective control over and accountability for federal funds and program income, compare outlays with budget amounts, and provide accounting records supported by source documentation.

• for any program incentives proposed, the specific internal controls that will be used to ensure only qualified participants will receive them and how they will be tracked.

• organizational controls that will ensure timely and accurate submission of Federal Financial Reports to the OASH Grants and Acquisitions Management Division via the Payment Management System as well as timely and appropriate withdrawal of cash from the Payment Management System.

https://www.ecfr.gov/current/title-2/part-200/section-200.313#p-200.313(e) https://www.ecfr.gov/current/title-2/part-200/section-200.313#p-200.313(e)

If your internal controls are available online, you may provide a link as part of your plan in the budget narrative. Although merit reviewers are not permitted to access any external materials linked in the application as part of their review, this link would facilitate review of your proposal if recommended for risk assessment (Section F.4).

Section J.5 contains questions you may find useful in preparing your Recipient Plans for Oversight of Federal Funds.

d. Project Abstract Summary Guidance

You must complete the Project Abstract Summary form. The application page limit does not include the Project Abstract Summary Form. Research projects may enter zero for “Estimated number of people to be served as a result of the award of this grant.”

The abstract will serve as the application summary going forward. Do not include sensitive or proprietary information in your abstract.

If your project is funded, we will publish the abstract on TAGGS.hhs.gov and USASpending.gov as you submitted it. You may request to edit it later, or we may ask you to edit it later to reflect any negotiated changes to the project. The abstract may also appear on the program office website or other government websites.

Your abstract should contain:

• Specifics about the project purpose

• Activities that you will perform

• Expected deliverables and outcomes

• Intended project beneficiary(ies) or participant(s)

Your description of the project should be brief and use plain language an average reader can understand. You should limit abbreviations, acronyms, or jargon without definitions. The abstract should be unique to your project.

The official complete application package is available on Grants.gov. Search either the Assistance Listing number or the NOFO number IR-ORI-25-003.

The package consists of several Adobe PDF format documents. This is a standard format widely accessible across multiple platforms including mobile devices. The Acrobat Reader application is available at https://www.adobe.com/acrobat/pdf-reader.html.

All materials will be under the Package tab on the page for this opportunity on Grants.gov. If you have problems locating the application package, contact:

OASH Grants and Acquisitions Management Division

1101 Wootton Parkway. Plaza Level