Revised NOFO_IR-ORI-24-001.pdf

U.S. Department of Health and Human Services

Office of Research Integrity

Notice of Funding Opportunity Ensuring Research Integrity - Conferences

Opportunity Number

IR-ORI-24-001

Application Due Date 04/11/2024 at 6:00 PM Eastern

Technical Assistance Webinar Date 02/09/2024 03:00 PM Eastern

OVERVIEW

Opportunity Title Ensuring Research Integrity - Conferences

Program Office Office of Research Integrity

Opportunity Number

IR-ORI-24-001

Application Submission and Format Electronic application submitted via Grants.gov

ONLY.

Award Type G (Grant)

Application Deadline 04/11/2024 06:00 PM Eastern

Announcement Type Initial

Technical Assistance Webinar Date 02/09/2024 03:00 PM Eastern

Assistance Listing 93.085

Technical Assistance Webinar Details https://ori.hhs.gov/

Eligible Applicants (see Section C.1 for full details) Public or nonprofit universities, hospitals, laboratories, and other institutions are eligible to apply for an award under this announcement.

Estimated Total Funding Available $200,000

Estimated Period of Performance (months)

Estimated Number of Awards

Estimated Award Date 05/31/2024

Funding Range $25,000 to $50,000 per budget period

Estimated Project Start Date 07/01/2024

QUESTIONS?

See contact information in Section G

EXECUTIVE SUMMARY

The Office of Research Integrity announces the anticipated availability of funds for Fiscal Year (FY) 2024 under the authority of 42 U.S.C. § 241 (Section 301, Title III of the Public Health Service Act).

This notice solicits applications for projects to plan and implement conferences on research integrity and compliance with 42 C.F.R. Part 93. In-person and virtual conferences, or a combination of both, will be considered for funding.

Conferences must provide a forum for discussion and produce tangible outcomes related to at least one of the following themes: 1) fostering an environment that promotes research integrity and the responsible conduct of research; 2) prevention of research misconduct; 3) effective handling of research misconduct allegations; or 4) other topics linked to research integrity and compliance with 42 C.F.R. Part 93.

We anticipate up to four one-year awards of between $25,000 and $50,000 in total costs (i.e., direct plus indirect costs).

The Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management Division (GAM) will administratively support this competition. GAM encourages all applicants to review all program requirements, eligibility information, application format and submission information, evaluation criteria, and other information in this notice to ensure that applications comply with all requirements and instructions.

Table of Contents

EXECUTIVE SUMMARY

A. PROGRAM DESCRIPTION

1. Background

2. Funding Opportunity Goals

3. Expected Performance Goals and Outcomes 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. Obtaining an 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. Merit 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. Award Closeout

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. Certain telecommunications and video surveillance services or equipment

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. Application Checklist

2. Acronyms

3. Glossary

4. Object Class Descriptions and Required Justifications

5. Considerations in Recipient Plans for Oversight of Federal Funds

6. Financial Assistance General Certifications and Representations

A. PROGRAM DESCRIPTION

The Office of Research Integrity announces the anticipated availability of funds for Fiscal Year (FY) 2024 under the authority of 42 U.S.C. § 241 (Section 301, Title III of the Public Health Service Act).

Research institutions applying for or receiving support from any of the Public Health Service (PHS) funding components (See Section H.3) to conduct biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training must meet the requirements of the PHS Policies on Research Misconduct (42 C.F.R. part 93). This includes “[fostering] 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 Conference Grant Program contributes to this mission by supporting conferences that advance the evolving field of research integrity and build the knowledge base in research misconduct, research integrity, and prevention of research misconduct and detrimental research practices (Section H.3). We seek to fund, through this opportunity, conferences that provide a forum for discussion of and produce tangible outcomes related to ensuring research integrity and compliance with 42 C.F.R. Part 93. In-person and virtual conferences, or a combination of both, will be considered for funding.

1. Background The purpose of this initiative is to provide assistance for those concerned with research integrity to meet to discuss theoretical, empirical, research design, educational, legal, procedural, ethical, and other aspects related to promoting the responsible conduct of research, preventing research misconduct, and/or addressing issues that arise after an allegation of research misconduct is brought forward at an institution.

For the purposes of this announcement, a conference is defined as a meeting, retreat, seminar, symposium, workshop, or event whose primary purpose is the dissemination of technical information beyond the recipient. Per 45 C.F.R. § 75.432, “[c]onference hosts/sponsors must exercise discretion and judgment in ensuring that conference costs are appropriate, necessary and managed in a manner that minimizes costs to the Federal award.” Applicants may seek additional sources of funding and institutional support to fund the proposed conference. Proposed conferences should be substantially distinct from and not duplicate existing ORI activities. This funding opportunity does not support projects with the primary purpose of developing, implementing, and/or running courses that require matriculation or employment at a specific institution or organization.

Proposed conferences must focus on at least one of the following themes:

1. fostering an environment that promotes research integrity and the responsible conduct of research;

2. prevention of research misconduct;

3. effective handling of research misconduct allegations; or

4. other topics linked to research integrity and compliance with 42 C.F.R. Part 93.

In addressing these themes, we encourage conferences that are designed to bring together experts from diverse areas of research, education, administration, law, and government to present research findings, discuss effective tools/programs/approaches, or facilitate discussions that lead to the development or implementation of new tools/programs/approaches to help prevent research misconduct and promote research integrity. We also encourage projects that include individuals actively engaged in or training for careers in research, and when practicable, take place in research settings. Illustrative examples of conference topics that may encompass these themes and participants are included below. The list is not exhaustive nor is it presented in order of importance or intended to indicate any preference for a specific theme.

• Identifying effective practices for the research integrity community to implement during various stages of institutional research misconduct proceedings. Practices could include sequestering evidence; preparing for and conducting interviews; defining the scope of the relevant research record; determining the quality/reliability of evidence;

remediating/protecting the research record; and protecting whistleblowers and preventing retaliation at an institutional level.

• Convening experts from diverse disciplines who can apply innovative, established, emerging, or promising models to develop interventions to prevent, deter, or address issues related to research misconduct or detrimental research practices. Collaboration with academic societies and associations and other national and international public and private organizations is encouraged, particularly when doing so will enhance outcomes or impact. Examples of enhanced outcomes or impact could include amplifying dissemination or diffusion as well as building coalitions.

• Developing networks to enable institutions to share and leverage knowledge and resources for handling allegations of research misconduct, addressing detrimental research practices, or promoting and fostering research integrity and the responsible conduct of research.

• Developing and proposing strategies, approaches, and recommendations for implementation of programs designed to facilitate compliance with federal and institutional requirements for promoting an environment that fosters research integrity and the responsible conduct of research.

2. Funding Opportunity Goals Projects awarded will contribute to the following programmatic goals for this funding opportunity:

Funding Opportunity Goals

a. The conference will provide a forum for discussion of issues related to research integrity, research misconduct, handling allegations of research misconduct, and/or compliance with 42 CFR Part 93.

b. The conference will provide the opportunity for participants to present research and/or discuss effective tools/programs/approaches that lead to the development or implementation of new tools/programs/approaches to help prevent research misconduct and promote research integrity.

c. The conference will provide the opportunity for members of the PHS funded research community to meet and establish networks that will support their efforts related to 42 CFR Part 93.

3. Expected Performance Goals and Outcomes for Funded Projects We will fund recipients to implement projects that meet the goals of this opportunity, including the requirement that recipients provide measurable objectives to gauge their success. Measurable objectives may include favorable outcomes and impacts.

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

a. Plan and implement a conference

We expect recipients to plan and implement a conference that provides a forum for discussion of and produces tangible, measurable outcomes related to at least one of the following themes:

1. fostering an environment that promotes research integrity and the responsible conduct of research;

2. prevention of research misconduct;

3. effective handling of research misconduct allegations; or

4. other topics linked to research integrity and compliance with 42 C.F.R. Part 93.

Tangible, measurable outcomes appropriate to the project may include demonstrated retention of knowledge, sharing of knowledge gained, change in practice, and/or strategies that can be operationalized to improve research integrity practices.

b. Assess conference outcomes

We expect recipients to develop and implement a comprehensive evaluation strategy to assess conference outcomes. Recipients may assess outcomes through post-event evaluation data or other appropriate means as they described in the approved application. Recipients should complete the evaluation activities within the period of performance and include the results in the final project report.

c. Disseminate knowledge and materials resulting from the conference

We expect recipients to develop and implement a comprehensive, time-framed dissemination plan to ensure that materials, products, and knowledge generated through the conference are disseminated beyond the participants attending the event. Although we encourage publication in peer-reviewed journals, recipients should work to achieve broad, multichannel, nationwide dissemination of materials and key points resulting from the conference. Where relevant, recipients should develop materials that are culturally and linguistically appropriate.

B. FEDERAL AWARD INFORMATION

1. Legal Authority Awards will be made under the legal authority in:

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. The actual amount available will not be determined until enactment of the FY 2024 federal budget.

We anticipate the total amount of funds available to be $200,000 for an estimated 4 competitive awards. Funding available for the first budget period will have a ceiling of $50,000 per award and a floor of $25,000.

We anticipate issuing notices of award 05/31/2024, with a project start date of 07/01/2024.

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 as a result of 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 subject to any offset with funds unused in the previous budget period.

C. ELIGIBILITY INFORMATION

1. Eligible Applicants Public or nonprofit universities, hospitals, laboratories, and other institutions are eligible to apply for an award under this announcement.

Eligible entities include public or nonprofit faith-based organizations, community-based organizations, and American Indian/Alaska Native/Native American (AI/AN/NA) organizations.

Eligible entities include public or nonprofit foreign organizations and foreign components of domestic organizations, if the proposed activity provides a domestic benefit, such as promoting research integrity among PHS-funded institutions both within the U.S. and abroad.

Additional 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

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 H.4 or your application will be disqualified (Section C.4). 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. You will not receive any preference, priority, or special consideration in the funding process for voluntarily including cost sharing in your proposed budget.

Awarded applications including cost sharing or matching commitment, whether required or voluntary, will include the commitment on the notice of award at the level proposed in the application (Section D.3.b). Any 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).

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:

• the Proposal Abstract Summary must clearly identify at least one of the following themes as the focus of the project:

1) fostering an environment that promotes research integrity and the responsible conduct of research;

2) prevention of research misconduct;

3) effective handling of research misconduct allegations; or

4) other topics linked to research integrity and compliance with 42 C.F.R. Part 93.

4. Application Disqualification Criteria Disqualification means we will not review the application and will give it no further consideration.

We will disqualify applications:

• not submitted electronically via Grants.gov

• not submitted by the due date and time indicated in this NOFO (unless an exemption was granted by the grants management officer in writing 2 business days prior to the deadline).

• submitted multiple times for the same project from the same organization, except for the last application received by the deadline.

• not completed or missing required forms in the application package found on Grants.gov including: SF-424; SF-424A, SF-LLL, and the Project Abstract Summary (Section D.2).

• not meeting the formatting requirements (Section D.2), specifically those:

o not in the English language and U.S. dollars (45 C.F.R. § 75.111(a)).

o not with an 8 ½ ” x 11” page size, with 1” margins on all sides (top, bottom, left and right).

▪ with a font size of not less than 12 points.

o with a Project Narrative that is not double-spaced o exceeding the 18 page limit for the Project Narrative.

o exceeding the total 60 page limit for the Project Narrative plus Appendices combined, excluding SF-424, SF-424A, SF-LLL, Project Abstract Summary, and Budget Narrative with budget tables.

• requesting total funds (direct plus indirect costs) that are either:

o Above the Award Ceiling of $50,000; or o Below the Award Floor of $25,000.

• lacking a non-federal sources justification in the budget narrative when including cost sharing (voluntary or required) (Section C.2).

• lacking and failing to address the Other – Application Responsiveness Criteria (Section C.3), if any.

https://grants.gov/

D. APPLICATION AND SUBMISSION INFORMATION

1. Obtaining an Application Package The complete application package is available on Grants.gov. Search either the Assistance Listing number (93.085) or the NOFO number (IR-ORI-24-001). All materials will be under the Package tab when on the NOFO webpage. If you have problems locating the application package, contact:

OASH Grants and Acquisitions Management Division

Phone: 240-453-8822

Email: OASH_Grants@hhs.gov

2. Content and Form of Application Submission Your application must be prepared using the forms and information provided in the online application package on Grants.gov. 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

Instructions for each form are found under the Related Documents tab on Grants.gov.

a. Project Narrative Formatting

Following the formatting instructions below will help ensure that your application is readable for review process.

1. 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. Although your organization may recognize co-PIs on team-managed projects, we recognize only a single PD/PI who will be responsible for the programmatic aspects of the project. Clearly identify the individual to be PD/PI in your application. We typically expect this to be the person named on the SF-424 in box 8.f.

Do not use a placeholder or honorary PD/PI because this does not present an accurate picture about who will be responsible for the day-to-day management of the project. 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.

http://Grants.gov mailto:OASH_Grants@hhs.gov?subject=NOFO%20inquiry

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. See Section F.2.c.

2. Page Formatting

If you submit documents that do not conform to the following instructions, GAM will disqualify your application during the review process. must double-space the Project Narrative pages.

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

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

Your project narrative and total application including appendices, must adhere to the page limits indicated in Section C.4. The page limit does not include the budget narrative (including budget tables), the required forms (SF-424, SF-424A, SF-LLL, and the Project Abstract Summary), and any required assurances/ certifications listed in Section C.3.

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 and total application (i.e., project narrative plus appendices (Section C.4)) when printed on 8.5” X 11” paper, the application will not be reviewed 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. Pages must not be reduced resulting in multiple pages on a single sheet to avoid exceeding the page limitation.

3. Electronic File Submission

We require that all applications be submitted electronically via the Grants.gov portal unless an exemption has been granted in writing by the grants management officer (See Section D.5).

Applications, excluding required standard forms, must be submitted as three (3) files.

File 1 the complete Project Narrative, File 2 the entire Budget Narrative including supporting documentation described in the Budget Narrative content section; and

File 3 all documents that make up the Appendices described in Section D.3.c.

Any additional files submitted as part of the Grants.gov application will not be accepted for processing and will be excluded from the application during the review process. Merit reviewers are not permitted to follow embedded links to materials outside of the application. Your content must fit within the page limits of the application.

We only accept the file formats identified below to ensure compatibility across our other systems even though Grants.gov will allow you to attach any file format. To be accepted under this NOFO, all files uploaded for your application must be in an acceptable file format and must contain a valid file format extension in the filename.

Acceptable File Formats (extension)

Unacceptable File Formats (extension)

• Adobe PDF (.pdf)

• Microsoft Word (.doc or

.docx)

• Image formats (.jpg, .gif, .tif, or .bmp only)

• Microsoft Excel files (.xls)

• Any compressed file formats

(e.g., .zip, .rar, or Adobe Portfolio)

• Any password-protected files

We strongly encourage you to upload your application in the Adobe PDF format. By converting to PDF prior to submission, you may prevent any unintentional changes that might occur with submission of an editable document. Most commonly available electronic document drafting tools have the ability to “Save As” or “Print To PDF.”

We do not recommend submitting scanned copies through Grants.gov unless you have confirmed the clarity of the scan and the readability of the documents.

Any file submitted as part of the Grants.gov application that is not in a file format listed above will not be accepted for processing and will be excluded from the application during the review.

We will not contact you for resubmission of files to correct the file type. We will not contact you for passwords or resubmission of unprotected files. Unprotected information in the application will be forwarded for consideration but password protected portions will not.

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

c. Appendices Format

Your appendices should include any specific items outlined in Section D.3.c. 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. All of your appendices must be uploaded as a single, consolidated file in the Attachments section of your Grants.gov application. We strongly encourage you to convert your file(s) to PDF format before uploading.

d. Project Abstract Summary Format

You must complete the Project Abstract Summary form. The application page limit does not include the Project Abstract Summary Form. Do not include sensitive or proprietary information in your abstract.

The abstract will serve as the application summary going forward. 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 changes to the project.

The abstract may also appear on the program office website or other government websites.

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

3. Application Content Successful applications will contain the following information:

a. Project Narrative Content

The Project Narrative is the most important part of your application, because 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 and provide the requested information.

1. Project Description

You should:

• Describe the proposed conference and how it will address the expectations identified in Section A.3 of this announcement. You should:

o Explain the rationale for the proposed conference.

o Define the gaps, needs, and/or issues on which the conference will focus.

o Describe the scope and breadth of the gaps, needs, and/or issues on which the conference will focus. Indicate if these are primarily national (U.S.) or international gaps, needs, and/or issues.

o Indicate how the proposed conference will contribute to addressing the identified gaps, needs, and/or issues nationally/internationally and how you envision the project will benefit the field at large.

o Describe the nature of the project activities and why you selected these specific activities. Present a clear connection between identified research integrity gaps, needs, and/or issues and the proposed activities. Explain how these activities will assist in achieving the overall project goals and objectives.

o Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the goals.

o Provide specifics about the proposed conference agenda, venue, speakers, attendees, and materials.

• Describe the target audience and how you will advertise the conference and encourage attendance. Describe the extent to which technology will play a role, if applicable.

• If a non-U.S. location is proposed, justify the selection of that location (e.g., estimate of how many people may travel from the U.S. to the conference for any role; connection to PHS-funded research, researchers or research institutions).

2. Innovation

You should:

• Describe any novel approaches or methods you intend to employ to fulfill the conference’s purpose. If you are utilizing approaches or methods that do not diverge substantially from existing practices, describe the novelty in the application of those methods to the project. Reference any existing approaches for the purpose of contrasting the novel approaches or methods you propose.

• Describe how the conference will draw together appropriate experts who may otherwise not convene on your chosen topic.

3. Outcomes

You should:

• Keep the focus of this section on describing what outcome(s) the project will produce. In many cases, it is very appropriate for a project to have only ONE outcome that it is trying to achieve through 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 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 or training sessions provided. These numbers in combination with other measures may contribute to the overall evaluation of the activity or project.

• Describe how you will report on the outcomes of the project.

4. Evaluation

You should:

• Describe the methods you will use to assess and evaluate the impact of the project activities.

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

• Describe how you will evaluate knowledge retention and application of the knowledge gained, changes in attitudes, or other key outcomes that may or may not emerge prior to the conclusion of the conference.

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

5. Dissemination

You should:

• Describe a comprehensive, time-framed dissemination plan to communicate key findings to stakeholders, the public, and others who might be interested in the results of the proposed project. We expect that nationwide dissemination of products and knowledge.

• Describe your strategies for broad, multichannel dissemination of key points and materials that emerge from conference events and activities.

• Describe how 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 others who might be interested in using the results of the project to inform practice, program development, and/or policy-making.

6. Project Management

You should:

• Identify the Principal Investigator/Project Director, collaborators, and other researchers, including subrecipients, contractors, and consultants, proposed for the project. This includes roles that research administrators, research integrity officers, research faculty, professional societies, publishers, editors, or others outside your organization will engage in accomplishing the project. Include a clear delineation of the roles and responsibilities of each contributor, their relevant experience, and how they will contribute to achieving the project’s goals and outcomes. Identify the level of effort each individual is anticipated to provide in completing programmatic activities.

• Clearly identify the Principal Investigator/Project Director and desccribe individual’s qualifications. You should reference that individual's CV or resume in your appendices.

We expect that, throughout the period of performance, 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 ongoing progress; preparation of reports; and communications with collaborators and HHS.

• Describe the approach that you will use to monitor and track progress on the project’s tasks and objectives. As appropriate, refer to the work plan in your Appendices (Section D.3.c).

7. Environment and Organizational Capability

You should:

• Describe the research/scientific environment of your organization and how it will contribute to the probability of success of the project.

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

This should include a description of the institutional support, equipment, and other physical resources available to the Principal Investigator/Project Director and other project personnel.

• Describe the organizational investment in the success of the Principal Investigator/Project Director 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 capabilities of your organization not included elsewhere in the program narrative, such as any current or previous relevant experience or the record of the project team in preparing cogent and useful reports, publications, and other products. As appropriate, refer to an organization chart in your Appendices (Section D.3.c) 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 (Section D.3.c).

• Describe the proposed in-person and/or virtual conference venue and articulate the characteristics or features of the venue that make it an appropriate setting for conference activities.

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

b. Budget Package Content

A complete budget package consists of the required standard form “Budget Information Non-construction Programs” (SF-424A) and a budget narrative with detailed justification. 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.

1. Standard Form SF-424A

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

You must provide an object class category budget for the first 12 months (i.e., first budget period) of the proposed project using Section B, box 6 of SF-424A. For awards with an estimated period of performance of one year 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.

2. Budget Narrative and Justification

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

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 H.4.

Project budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. Carefully review Section D.7 Funding Restrictions for specific information regarding allowable, unallowable, and restricted costs.

For each proposed cost for the first budget period of the project, provide a budget justification, which includes explanatory text and line-item detail. The budget narrative should describe how you derived the categorical costs. Discuss the necessity and reasonableness of the proposed costs for the project you propose.

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 year, provide a detailed justification explaining these changes. Funding for all approved budget periods after the first is generally the same as the initial award amount subject to offset with funds unused in the previous budget period.

Preparing the Budget Narrative

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

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.

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

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 H.4) 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).

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

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

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

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.

If your internal controls are available online, you may provide the 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 E.3).

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

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

c. Appendices

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.

Work Plan

Include a detailed work plan that is consistent with your project narrative and budget narrative.

Your work plan should cover all years of the estimated period of performance.

A work plan should include a statement of the project’s overall goal(s), key SMARTIE objectives (specific, measurable, achievable, relevant, time-bound, inclusive, and equitable), milestone activities, and anticipated measurable outcome(s)/impact(s). Your objectives should align with the expectations of this opportunity, and the major tasks, action steps, or activities to achieve the goal and outcome(s). For each major task, action step, or activity, the work plan should identify the person(s) responsible, the timeline for completing activities (including start-and end-dates), and measures of success.

A suggested Work Plan Template is included under Related Documents in grants.gov (the instruction pages will not count toward your page limit) or you may create your own work plan.

Regardless of the option you choose, the work plan you submit must address all of the content requested.

Documentation of Level of Commitment

Submit documentation to support the level of commitment of any partners or collaborators you have described as having essential or important roles in the project’s success.

Documentation of commitment is typically a Memorandum of Agreement (MOA) or a Letter of Commitment (LOC). A signed MOA generally demonstrates a higher level of commitment between the partners or collaborators. LOCs are typically a precursor to an MOA that the partners or collaborators sign before a project begins.

Data Sharing Agreements (DSAs) are a type of documentation of commitment that establish the parameters and responsibilities related to data collection, storage, and sharing. See Section F.6 for information about the federal governments interests in any data produced under an award under this NOFO.

Do not provide copies of contracts.

Regardless of what you call your document, it should include specific roles, responsibilities (including specific activities), resources, and contributions of the partner(s) or collaborator(s) to the project. The document should also describe each partner’s or collaborator’s specific expertise, experience, and access to the targeted population(s) or community(ies). It is your responsibility to ensure that all partners and collaborators have the necessary understanding of their roles to participate in the project.

If signed documentation for one or more partners or collaborators are not available when you submit your application, submit an unsigned draft of the document and the anticipated date of having all signatures.

Fully-executed DSAs and MOAs identified for essential roles in the project will be required within the first 30 days of the period of performance for any award made under this announcement. Special conditions may be applied to an award that does not meet this deadline.

Letters of support are not the same as MOAs and LOCs. Letters of support are general in nature and speak to the writer’s belief in the capability of an applicant to accomplish a goal/task.

Letters of support also may indicate an intent or interest to work together in the future, but they lack specificity. You should NOT provide letters of support, and letters of support will not be considered during the review.

Curricula Vitae, Résumés, Biographical sketches for Key Project Personnel

Submit curricula vitae, résumés, or biographical sketches (biosketches) for all key project personnel including the Project Director/Principal Investigator (PD/PI). Key personnel includes those individuals who will oversee the technical, professional, managerial, and support functions and/or assume responsibility for assuring the validity and quality of the project. Do not include curricula vitae, résumés, or biosketches for individuals who provide routine administrative support to the project as part of their broader support of the organization. For key personnel positions that are currently vacant, please provide a copy of the position description or a list of duties for the position.

You should use full names (first, middle, last) on these documents to distinguish them for verification in the System for Award Management exclusion records. Use the formatting common to those documents. (See https://grants.nih.gov/grants/forms/biosketch.htm for templates and sample biographical sketches.)

References Cited

Include your references cited in your project narrative. You may use any standard format that you choose as long as it clearly leads the reader to your source of the information or data.

Description of Facilities and Resources Available

Describe how the environment in which the in-person/virtual conference will be held contributes to the probability of success (e.g., institutional support, physical resources, geographic location, intellectual rapport).