NOFO IR-ORI-23-001.pdf

U.S. Department of Health and Human Services

Office of Research Integrity

Notice of Funding Opportunity: Ensuring Research Integrity - Research, Development, and Demonstration

Opportunity Number: IR-ORI-23-001

Application Due Date:

05/10/2023 at 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

The Office of the Assistant Secretary for Health, Office of Research Integrity

FUNDING OPPORTUNITY TITLE

Ensuring Research Integrity - Research, Development, and Demonstration

ACTION

Notice

ANNOUNCEMENT TYPE

Initial G (Grant)

FUNDING OPPORTUNITY NUMBER

IR-ORI-23-001

ASSISTANCE LISTING NUMBER AND PROGRAM:

93.085 , Research on Research Integrity

DATES

Application Deadline: 05/10/2023 by 6:00 PM Eastern.

Technical Assistance Webinar: 03/23/2023 at 3:00 PM Eastern.

EXECUTIVE SUMMARY

The Office of Research Integrity announces the availability of funds for Fiscal Year (FY) 2023 under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

This notice solicits applications for projects that will: 1) conduct research, to address one or more of the four focus areas identified below, related to ensuring research integrity and compliance with 42 C.F.R. Part 93; 2) develop innovative approaches/tools/resources based on the results of this research; and 3) demonstrate the impact and/or effectiveness of these approaches/tools/resources.

The purpose of this initiative is to provide assistance to recipients to promote the integrity and reliability of PHS-funded research through the development and implementation of innovative practical approaches/tools/resources that improve practices related to one of the following four focus areas: 1) transparency in the reporting of research; 2) effective communication between researchers for the purpose of avoiding, mitigating, and resolving issues related to authorship and/or collaboration; 3) handling allegations of research misconduct under 42 C.F.R. Part 93; or

4) interventions to address issues related to research culture and climate (e.g., overly-competitive environments, toxic workplaces, bullying, harassment, etc.) that can negatively impact the integrity, conduct, quality, and reliability of research. We anticipate three to six awards of between $75,000 and $150,000 in total costs (direct plus indirect) per year, for a total project period not to exceed two years (two 12-month project periods and budget periods).

The Office of the Assistant Secretary for Health (OASH) encourages all applicants to review all program requirements, eligibility information, application format and submission information, evaluation criteria, and other information in this funding announcement to ensure that their applications comply with all requirements and instructions.

Table of Contents

OVERVIEW

FEDERAL AGENCY NAME

FUNDING OPPORTUNITY TITLE

ACTION

ANNOUNCEMENT TYPE

FUNDING OPPORTUNITY NUMBER

ASSISTANCE LISTING NUMBER AND PROGRAM:

DATES

EXECUTIVE SUMMARY

A. Program Description

1. Background

2. Expectations for Funded Projects

B. Federal Award Information

1. Legal Authority

2. Award Information

C. Eligibility Information

1. Eligible Applicants

2. Cost Sharing or Matching

3. Other - Application Responsiveness Criteria

4. Application Disqualification Criteria

D. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

2. Content and Form of Application Submission

3. Application Content

4. Unique Entity Identifier and System for Award Management (SAM)

5. Submission Dates and Times

6. Intergovernmental Review

7. Funding Restrictions

8. Other Submission Requirements

E. APPLICATION REVIEW INFORMATION

1. Criteria

2. Review and Selection Process

3. Review of Risk Posed by Applicant

4. Final Award Decisions, Anticipated Announcement, and Federal Award Dates

F. FEDERAL AWARD ADMINISTRATION INFORMATION

1. Federal Award Notices

2. Administrative and National Policy Requirements

3. Program Specific Terms and Conditions

4. Closeout of Award

5. Lobbying Prohibitions

6. Non-Discrimination Requirements

7. Smoke- and Tobacco-free Workplace

8. Acknowledgement of Funding

9. HHS Rights to Materials and Data

10. Trafficking in Persons

11. Efficient Spending

12. Whistleblower Protection

13. Health Information Technology (IT) Interoperability

14. Prohibition on certain telecommunications and video surveillance services or equipment. 40

15. Human Subjects Protection

16. Research Integrity

17. Reporting

G. CONTACTS

1. Administrative and Budgetary Requirements

2. Program Requirements

3. Electronic Submission Requirements

H. OTHER INFORMATION

1. Awards under this Announcement

2. Application Elements

I. SUPPLEMENTARY MATERIALS

1. Acronyms

2. Considerations in Recipient Plans for Oversight of Federal Funds

3. Financial Assistance General Certifications and Representations

4. Public Health Service Funding Components

A. Program Description The Office of Research Integrity announces the availability of funds for Fiscal Year (FY) 2023 under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

Research institutions applying for or receiving support for research from any of the Public Health Service (PHS) funding components (See I.4) for any activity or program that involves the conduct of biomedical or behavioral research, research training, or activities related to that research or research training are required 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). 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…to respond effectively to allegations of research misconduct” (65 F.R. 30600, 30601).

Our Ensuring Research Integrity - Research, Development, and Demonstration Grant Program contributes to this mission by supporting projects that undertake research, development, and demonstration activities to advance the evolving field of research integrity as well as to develop innovative practical approaches, tools, and/or resources, and produce tangible outcomes related to ensuring research integrity and compliance with 42 C.F.R. Part 93.

1. Background

The purpose of this initiative is to provide assistance to recipients to promote the integrity and reliability of PHS-funded research through the development and implementation of innovative practical approaches, tools, and/or resources that improve practices in a focus area(s) related to research integrity and compliance with 42 C.F.R Part 93. We have selected the following four focus areas for Fiscal Year 2023:

1. Transparency in the reporting of research.

2. Effective communication between researchers for the purpose of avoiding, mitigating, and resolving issues related to authorship and/or collaboration – These issues include authorship/collaborator disputes and/or issues related to the integrity of the research (e.g., conflicts of interest, research integrity, rigor, reproducibility, transparency, reliability).

3. Handling allegations of research misconduct under 42 C.F.R. Part 93.

4. Interventions to address issues related to research culture and climate (e.g., overly-competitive environments, toxic workplaces, bullying, harassment, etc.) that can negatively impact the integrity, conduct, quality, and reliability of research – Interventions may include activities that promote a positive culture/climate or inhibit the perpetuation of a negative climate/culture.

This notice solicits applications for projects that will:

1. conduct research, to address one or more of the four focus areas identified above, related to ensuring research integrity and compliance with 42 C.F.R. Part 93;

2. develop innovative approaches/tools/resources based on the results of this research; and

3. demonstrate the impact and/or effectiveness of these approaches/tools/resources.

The project should contain feasible ideas with tangible/measurable outcomes supported by an appropriate budget request and work plan to meet the Expectations of this announcement and project goals. The proposed project period must not exceed two years (i.e., two 12-month budget periods). You may propose a shorter project period of one year if the project goals and outcomes are achievable within that period. Funding after the first budget period will require submission of a non-competing continuation application for a second budget period for any project period exceeding 12 months. Funding for the second budget period will be contingent upon availability of funding, satisfactory performance (including recipient progress towards meeting stated project milestones and goals, timely submission of required reports, and compliance with all grant terms and conditions), and the best interests of the government. This funding opportunity does not support projects with the primary purpose of holding meetings, conferences, or workshops. See opportunity number IR-ORI-23-002 for those purposes.

We encourage proposed projects to include collaboration or consultation with individuals and/or organizations with experience in handling issues or providing guidance related to research integrity, research climate/culture, the responsible conduct of research, and/or compliance with 42 C.F.R Part 93. This may include, but is not limited to, institutional research integrity officers;

professional organizations; others who have direct experience with 42 C.F.R. Part 93;

and institutional attorneys experienced with these matters. We also encourage proposed projects to include individuals actively engaged in, or training for, careers in research, and whenever practical, to take place in research settings.

2. Expectations for Funded Projects

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

a. Conduct research related to ensuring research integrity

We expect that the recipient will conduct research for the purpose of informing the development and implementation of innovative practical approaches, tools, and/or resources that improve practices in one or more of the FY 2023 focus areas below.

We expect that research activities and all other activities of the proposed project will concentrate on addressing one or more of the four FY 2023 focus areas:

1. Transparency in the reporting of research.

2. Effective communication between researchers for the purpose of avoiding, mitigating, and resolving issues related to authorship and/or collaboration – These issues include authorship/collaborator disputes and/or issues related to the integrity of the research (e.g., conflicts of interest, research integrity, rigor, reproducibility, transparency, reliability).

3. Handling allegations of research misconduct under 42 C.F.R. Part 93.

4. Interventions to address issues related to research culture and climate (e.g., overly-competitive environments, toxic workplaces, bullying, harassment, etc.) that can negatively impact the integrity, conduct, quality, and reliability of research – Interventions may include activities that promote a positive culture/climate or inhibit the perpetuation of a negative climate/culture.

b. Develop innovative and practical approaches, tools, and/or resources

We expect that the recipient will develop, based on the results of the research described above, innovative and practical approaches, tools, and/or resources (collectively, “materials”) that will contribute to researchers’ and institutions’ efforts to ensure the integrity and reliability of PHS-funded research and/or compliance with 42 C.F.R. Part 93. Recipients should design and develop these materials such that they can be directly used or implemented to facilitate improved practices at the level of the relevant stakeholder (i.e., individual researcher/research group, research administrator, or research institution). Materials requiring customization for a specific research setting and/or discipline should be readily adaptable. Additionally, recipients should design all materials with ease of use and implementation for the end user in mind. Where relevant, recipients should develop materials that are culturally and linguistically appropriate.

c. Demonstrate the impact and/or effectiveness of the materials developed

We expect the recipient to implement and evaluate the materials developed above to determine the ease with which they can be directly used by the relevant stakeholder(s) (i.e., individual researcher/research group, research administrator, or research institution), their effectiveness in facilitating improved practices, and their impact on research integrity and/or compliance with 42 C.F.R. Part 93. 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.

d. Disseminate the materials developed

We expect that, as relevant, the recipient will make relevant stakeholders aware of the availability of and provide free access to the materials developed above. The purpose of this funding opportunity and dissemination of the resulting materials is to support the improvement of practices and ensure the integrity of PHS-funded research and/or compliance with 42 C.F.R.

Part 93.

We expect that the recipient will develop and implement a comprehensive, time-framed dissemination plan to communicate key findings to stakeholders, the public, and other parties who might be interested in the results of the proposed project. Recipients' plan should include a description of the method that will be used 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 other parties who might be interested in using the results of the project.

B. Federal Award Information

1. Legal Authority

42 U.S.C. § 241 (Section 301 of the Public Health Service Act)

2. Award Information

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

We will fund awards in annual increments and generally for a period of performance up to 2 year(s), although we may approve shorter periods of performance. Budget periods may also vary from the estimate indicated below due to timing of award issuance or other administrative factors.

Recipients will be required to submit a non-competing continuation application for each budget period after the first. Funding for all approved budget periods beyond the first is generally level with the initial award amount and is contingent upon the availability of funds, satisfactory progress of the project, adequate stewardship of Federal funds, and the best interests of the Government.

Award Information

Estimated Federal Funds Available $450,000

Anticipated Number of Awards 3

Award Ceiling (Federal Funds including indirect costs) $150,000 per budget period

Award Floor (Federal Funds including indirect costs) $75,000 per budget period

Anticipated Start Date 07/15/2023

Estimated Period of Performance Not to exceed 2 year(s)

Anticipated Initial Budget Period Length 12 months

Type of Award Grant

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

C. Eligibility Information

1. Eligible Applicants

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

Faith-based organizations and American Indian/Alaskan Native/Native American (AI/AN/NA) organizations that are public or private entities are eligible to apply.

Community-based organizations are eligible to apply.

Foreign institutions (non-domestic U.S.) entities and foreign components of U.S. organizations are eligible to apply. To receive an award the proposed activity must provide a domestic benefit, such as promoting research integrity among PHS-funded institutions both within the U.S. and abroad.

Examples of eligible organizations include:

State governments

County governments

City or township governments

Special district governments

Independent school districts

Public and State controlled institutions of higher education

Native American tribal governments (Federally recognized)

Public housing authorities/Indian housing authorities

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

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

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

Private institutions of higher education

Individuals

For profit organizations other than small businesses

Small businesses

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget. If you voluntarily include cost sharing in your application, you must include in your budget narrative a non-federal sources justification as described in Section D.3.b.1.t or your application will be disqualified (Section C.4.k). Voluntary cost sharing is not expected for research applications. During the merit review of an application, cost sharing will only be considered in the overall review of the adequacy of the total proposed budget (Federal and non-Federal share) to support the project proposed.

Applications including cost sharing or matching, whether required or voluntary, that result in an award will include the cost sharing or matching commitment on the notice of award at the level proposed in the application. See Section D.3.b.1.s. Any change in the responsibility to provide cost sharing or matching at that level will require prior approval of the grants management officer.

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

3. Other - Application Responsiveness Criteria

We will review your application to determine whether it meets the responsiveness criteria below.

If your application does not meet the responsiveness criteria, we will disqualify it from the competition; we will not review it beyond the initial screening. The responsiveness criteria are as follows:

There are no Other - Application Responsiveness Criteria.

4. Application Disqualification Criteria

If you successfully submit an application, the OASH Grants and Acquisitions Management (GAM) Division will determine whether your application is eligible according to section C.1 Eligible Applicants. If we determine your application fails to meet the criteria described below, we will disqualify it, that is, we will not review it and will give it no further consideration.

a. You must submit your application electronically via https://grants.gov/ (unless an exemption was granted by the grants management officer 2 business days prior to the deadline) by the date and time indicated in Section D.5 of this announcement.

https://grants.gov/

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

c. You must complete the required forms in the application package: SF-424, SF-424A, SF-LLL, and Project Abstract Summary (Section D.2.a).

d. Your application must be submitted in the English language and must be in terms of U.S. dollars (45 C.F.R. § 75.111(a)).

e. Your Project Narrative section of the application must be double-spaced, on the equivalent of 8 ½ ” x 11” page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points (Section D.2.a).

f. Your Project Narrative must not exceed 30 pages. The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-LLL, Project Abstract Summary, and Budget Narrative (including budget tables)(Section D.2.a).

g. Your total application (i.e., the Project Narrative plus Appendices) must not exceed 75 pages. The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF- LLL, Project Abstract Summary, and Budget Narrative (including budget tables)(Section D.2.a).

h. Your Federal funds request including indirect costs must not be above the maximum indicated in Award Ceiling (Section B.2).

i. Your Federal funds request including indirect costs must not be below the Minimum indicated in Award Floor, if any (Section B.2).

j. Your application must meet the Other - Application Responsiveness Criteria outlined above (Section C.3).

k. If your application includes cost sharing (voluntary or required, Section C.2), you must include in your budget narrative a non-federal sources justification.

D. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

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

OASH Grants and Acquisitions Management Division

Phone: 240-453-8822

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

2. Content and Form of Application Submission

a. Application Format

Your application must be prepared using the forms and information provided in the online application package. This includes but is not limited to:

SF-424 Application for Federal Assistance SF-424A Budget Information for Non-Construction Programs SF-LLL Disclosure of Lobbying Activities Project Abstract Summary

We encourage individuals to use their full name (first, middle, last) on the Standard Forms and other documents such as résumés/curricula vitae/biographical sketches to distinguish them for verification in the System for Award Management exclusion records. Delays may result in award processing if full names are not provided.

Only one Project Director/Principal Investigator (PD/PI) will be named on any resulting award.

You should clearly identify the individual in that role in your application. This individual should be the person who will be responsible for the programmatic aspects of the project if an award is made. A placeholder PD/PI is strongly discouraged because this may not present a clear picture for the review. Furthermore, once an award is issued a request for a change in PD/PI requires prior approval of the grants management officer (45 C.F.R. § 75.308(c)(1)(ii-iii)).

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section C.4. The page limit does not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria.

You must double-space the Project Narrative pages.

Your application must be submitted in the English language and must be in the terms of U.S.

dollars (45 C.F.R. § 75.111(a))

You should use an easily readable typeface, such as Times New Roman or Arial. You must use 12-point font. You may single-space tables or use alternate fonts but you must ensure the tables are easy to read.

Please do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete. If your application exceeds the specified page limits for the Project Narrative or Project Narrative plus Appendices (Section C.4(f)-(g)) when printed on 8.5” X 11” paper as determined by OASH/GAM, the application will not be reviewed further. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

b. Appendices Format

Your appendices should include any specific documents outlined in Section D.3.c, under the heading “Appendices” in the Application Content section of this announcement. Your documents should be easy to read. You should use the same formatting specified for the Project Narrative.

However, documents such as résumés/curricula vitae, organizational charts, tables, or letters of commitment may use formatting common to those documents, but the pages must be easy to read. All of your appendices must be uploaded as a single, consolidated file in the Attachments section of your Grants.gov application.

c. Project Abstract Summary Format

You must complete the Project Abstract Summary form provided in the application package. The abstract will be used to provide reviewers with an overview of the application and will form the basis for the application summary in grants management and program summary documents.

Furthermore, if your project is funded, HHS will publish the abstract from your form on TAGGS.hhs.gov and USASpending.gov. The abstract may also appear on the program office website or other government website. Therefore, do not include sensitive or proprietary information in your abstract.

Research awards may enter zero for “Estimated number of people to be served as a result of the award of this grant."

d. Budget Narrative Format

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

3. Application Content

Successful applications will contain the following information:

a. Project Narrative Content

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether your project meets the minimum requirements for an award under this announcement. The Project Narrative should provide a clear and concise description of your project. HHS/OASH recommends that your project narrative include the following components:

1. Project Description

You should:

Describe the proposed project and how it will address the Expectations identified in Section A.2 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

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.

4. Dissemination

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.

5. Project Management

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.

6. Environment and Organizational Capability

You should:

Provide a contingency plan for modification of in-person activities in the event of a resurgence of COVID-19 or precautions under other public health emergency conditions.

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. Budget Narrative Content

You must complete the required budget forms and submit a budget narrative with detailed justification as part of your application. You must enter the project budget on the Budget Information Non-construction Programs standard form (SF-424A) according to the directions provided with this standard form. The budget narrative consists of a detailed line-item budget that includes calculations for all costs and activities by "object class categories" identified on the SF-424A and justification of the costs.

Project budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. If matching or cost sharing is required, you must include a detailed listing of any funding sources identified in box 18 of the

SF-424 (Application for Federal Assistance). You must state the method you are selecting for your indirect cost rate. See Indirect Costs (Section D.3.b.1.o)) for further information. If you are providing in-kind contributions of any type or value, including costs otherwise covered by your indirect cost rate, you must identify those costs, and you should, as appropriate, include the value of the in-kind contribution as proposed cost-sharing (voluntary or required ) (45 C.F.R. § 75.306).

Please be sure to carefully review Section D.7 Funding Restrictions for specific information regarding allowable, unallowable, and restricted costs.

You must provide an object class category budget using Section B, box 6 of the SF-424A for the first year of the proposed project. For awards with an anticipated period of performance of one year or less, this will be the budget request for the entire project. Provide a budget justification, which includes explanatory text and line-item detail, for the entire first year of the proposed project. The budget narrative should describe how the categorical costs are derived. Discuss the necessity, reasonableness, and allocation of the proposed costs.

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

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

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

Use the following guidelines for preparing the detailed object class budget required by box 6 of the SF-424A. The object class budget organizes your proposed costs into a set of defined categories outlined below. Both federal and non-federal resources (if applicable) must be detailed and justified in the budget narrative. "Federal resources" refers only to the HHS/OASH funds for which you are applying under this NOFO. "Non-federal resources" are all other non- HHS/OASH federal and non-federal resources. We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested; third column, non-federal resources; and last column, total budget.

Sample Budget Table Object Class Federal Funds

Requested Non-federal Resources

Total Budget

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

Subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items. For example, subrecipient travel should be included in the Contractual line item not in Travel. Subrecipient/contract and consultant activities must be described in sufficient detail to describe accurately the project activities that each will conduct.

1. Object Class Descriptions and Required Justifications

a. Personnel Description

Costs of staff salaries and wages, excluding benefits.

b. Personnel Justification

Clearly identify the PD/PI, if known at the time of application. Provide a separate table for personnel costs detailing for each proposed staff person: the title; full name (if known at time of application), time commitment to the project as a percentage or full-time equivalent: annual salary and/or annual wage rate; federally funded award salary; non-federal award salary, if applicable; and total salary. No salary rate may exceed the statutory limitation in effect at the time you submit your application (see D.7.2) Funding Restrictions, Salary Rate Limitation for details). Do not include the costs of consultants, personnel costs of delegate agencies, or of specific project(s) and/or businesses to be financed by the applicant. Contractors and consultants should not be placed under this category.

Sample Personnel Table Position Title and Full Name Percent Time

Annual Salary

Federally -funded Salary

Non-federal Salary

Total Project Salary

Project Director, John K. Doe

50% $100,000 $50,000 $0 $50,000

Data Assistant, Susan R. Smith

10% $30,000 $3,000 $3,000

c. Fringe Benefits Description

Costs of employee fringe benefits unless treated as part of an approved indirect cost rate.

d. Fringe Benefits Justification Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, Federal Insurance Contributions Act (FICA) taxes, retirement insurance, and taxes.

e. Travel Description Costs of travel by staff of the applicant organization only. Do not include travel costs for subrecipients or contractors under this object class.

f. Travel Justification For each trip proposed for applicant organization staff only, show the date of the proposed travel, total number of traveler(s); travel destination; duration of trip; per diem; mileage allowances, if privately owned vehicles will be used; and other transportation costs and subsistence allowances. Do not include travel costs for subrecipients or contractors under this object class.

g. Equipment Description Equipment means tangible personal property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds the lesser of the capitalization level established by the non- Federal entity for financial statement purposes, or $5,000. (Acquisition cost means the cost of the asset including the cost to ready the asset for its intended use.

Acquisition cost for equipment, for example, means the net invoice price of the equipment, including the cost of any modifications, attachments, accessories, or auxiliary apparatus necessary to make it usable for the purpose for which it is acquired. Acquisition costs for software includes those development costs capitalized in accordance with generally accepted accounting principles (GAAP). Ancillary charges, such as taxes, duty, protective in transit insurance, freight, and installation may be included in or excluded from the acquisition cost in accordance with the non- Federal entity’s regular accounting practices.) See 45 C.F.R. § 75.2 for additional information.

h. Equipment Justification For each type of equipment requested you must provide a description of the equipment; the cost per unit; the number of units; the total cost; and a plan for use of the equipment in the project; as well as a plan for the use, and/or disposal of, the equipment after the project ends. An applicant organization that uses its own definition for equipment should provide a copy of its policy, or section of its policy, that includes the equipment definition; include this with your Budget Narrative file.

Reference the policy in this justification and include the policy copy in your Budget Narrative file (not your appendices).

i. Supplies Description

Costs of all tangible personal property other than those included under the Equipment category. This includes office and other consumable supplies with a per-unit cost of less than $5,000.

j. Supplies Justification Specify general categories of supplies and their costs. Show computations and provide other information that supports the amount requested.

k. Contractual Description

Costs of all contracts or subawards for services and goods except for those that belong under other categories such as equipment, supplies, construction, etc. Include third-party evaluation contracts, if applicable, and contracts or subawards with subrecipient organizations (with budget detail), including delegate agencies and specific project(s) and/or businesses to be financed by the applicant. This line item is not for individual consultants.

l. Contractual Justification

Demonstrate that all procurement transactions will be conducted in a manner to provide, to the maximum extent practical, open, and free competition. Recipients and subrecipients are required to use 45 C.F.R. § 75.329 procedures and must justify any anticipated procurement action that is expected to be awarded without competition and exceeds the simplified acquisition threshold fixed by 41 U.S.C. § 134 and currently set at $250,000. Recipients may be required to make pre-award review and procurement documents, such as requests for proposals or invitations for bids, independent cost estimates, etc., available to HHS/OASH.

Whenever you intend to transfer a substantive part of the project effort to another entity (including non-employee individuals), you must provide a detailed budget and budget narrative for each subrecipient/contractor, by title/name, along with the same supporting information referred to in these instructions. If you plan to select the subrecipients/contractors post-award and a detailed budget is not available at the time of application, you must provide information on the nature of the work to be transferred, the estimated costs, and the process for selecting the subrecipient/contractor.

m. Other Description

Enter the total of all other costs. Such costs, where applicable and appropriate, may include but are not limited to: consultants; insurance; professional services (including audit charges); space and equipment rent; printing and publication; training, such as tuition and stipends; participant support costs including incentives, staff development costs; and any other costs not addressed elsewhere in the budget.

n. Other Justification

Provide computations, a narrative description, and a justification for each cost under this category.

o. Indirect Costs Description

Total amount of indirect costs. This category has one of two methods that you may select. You may only select one and must clearly identify that selection in your submitted budget.

Your organization currently has an indirect cost rate approved by the Department of Health and Human Services (HHS) or another cognizant federal agency. You should enclose a copy of the current approved rate agreement in your Budget Narrative file. If you request a rate that is less than allowed, your authorized representative must submit a signed acknowledgement that the organization is accepting a lower rate than allowed.

Per 45 C.F.R. § 75.414 (f) Indirect (F&A) costs, “any non-Federal entity [i.e., applicant] that has never received a negotiated indirect cost rate, … may elect to charge a de minimis rate of 10% of modified total direct costs (MTDC) which may be used indefinitely. As described in § 75.403, costs must be consistently charged as either indirect or direct costs, but may not be double charged or inconsistently charged as both. If chosen, this methodology once elected must be used consistently for all Federal awards until such time as a non-Federal entity chooses to negotiate for a rate, which the non-Federal entity may apply to do at any time.”

The de minimis rate method only applies if you have never received an approved negotiated indirect cost rate from HHS or another cognizant federal agency. If you are waiting for approval of an indirect cost rate, you may request the 10% de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs to the award.

Indirect costs on Federal awards for training are limited to a fixed rate of eight percent of 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)).

p. Indirect Costs Justification

Provide the calculation for your indirect costs total, i.e., show each line item included in the base, the total of these lines, and the application of the indirect rate.