PKG00262077-instructions.pdf

DEPARTMENT OF

HEALTH AND HUMAN SERVICES

OFFICE OF THE

ASSISTANT SECRETARY FOR HEALTH

Office of Research Integrity

Funding Opportunity: IR-ORI-20-002

Opportunity Number: 93.085

Application Due Date:

Tuesday, August 4, 2020 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

Office of the Assistant Secretary for Health / Office of Research Integrity

FUNDING OPPORTUNITY TITLE

Announcement of the Availability of Funds for Conferences on Research Integrity

ACTION

Notice

ANNOUNCEMENT TYPE

Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER

IR-ORI-20-002

CFDA NUMBER AND PROGRAM:

93.085 Research of Responsible Conduct

DATES

Application Deadline: Tuesday, August 4, 2020 by 6:00 PM Eastern.

Technical Assistance: Webinar Thursday, June 25, 2020 at 1:00 PM Eastern

EXECUTIVE SUMMARY

The Office of Research Integrity (ORI) announces the anticipated availability of funds for

Fiscal Year (FY) 2020 grant awards under the authority of Sec. 301 of the Public Health Service

Act, 42 U.S.C. § 241, as delegated to the Director of ORI.

This notice solicits applications for projects to plan and implement conferences or workshops on research integrity and compliance with 42 C.F.R. Part 93. Virtual conferences, and workshops will be eligible for funding.

Conferences or workshops must be designed to provide a forum for discussion and produce tangible outcomes related to at least one of the following themes: 1) Responsible Conduct of

Research (RCR) training; 2) fostering an environment that promotes research integrity; 3) prevention of research misconduct; 4) effective handling of research misconduct allegations; 5) whistleblowing and protection of whistleblowers; or, 6) other topics linked to research integrity and compliance with 42 C.F.R. Part 93. ORI anticipates awarding two to four one-year grants, up to $50,000 each, for a total funding amount of $100,000. Eligibility requirements are described below.

HHS/OASH encourages 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 its application complies with all requirements and instructions.

FUNDING OPPORTUNITY DETAILS

A. DATES

1. Application Deadline

Your application is due Tuesday, August 4, 2020 by 6 p.m. Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time. If you do not submit your application by the specified deadline, we will return it to you unread. You must submit electronically via Grants.gov unless you obtain a written exemption from this requirement 2 business days in advance of the deadline from the Director, HHS/Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management

(GAM) Division. To obtain an exemption, you must request one via email from the

HHS/OASH/GAM, and provide details as to why you are technologically unable to submit electronically through Grants.gov. Your request should be submitted at least 4 business days prior to the application deadline to ensure your request can be considered prior to 2 business days in advance of the deadline. If you request an exemption, include the following in your e-mail request:

the HHS/OASH announcement number; your organization's DUNS number; your organization’s name, address and telephone number; the name and telephone number of your Authorizing

Official; the Grants.gov Tracking Number (for example, GRANT####) assigned to your submission; and a copy of the "Rejected with Errors" notification from Grants.gov. Send the request with supporting documentation to OASH_Grants@hhs.gov. Note: failure to have an active

System for Account Management (SAM) registration prior to the application due date will not be grounds for receiving an exemption to the electronic submission requirement. As a result of the public health emergency for COVID-19, the requirement for an active SAM registration at the time of application submission has been waived (see Section F.4). However, if you do not have a

DUNS number at this time, you should contact Grants.gov to establish a temporary DUNS number.

Your application will not be accepted through Grants.gov without this number. Failure to follow

Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

The HHS/OASH/GAM will only accept applications via alternate methods (hardcopy paper via U.S. mail or other provider or PDF via email) from applicants obtaining prior written approval. If you receive an exemption, you must still submit your application by the deadline.

Only applications submitted through the Grants.gov portal or alternate format (hardcopy paper via

U.S. mail or other service or PDF via email) with an approved written exemption will be accepted.

mailto:ogm.oash@hhs.gov

See Section F.8 (“Other Submission Requirements”) for information on application submission mechanisms.

To ensure adequate time to submit your application successfully, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. You must register an authorizing official for your organization. HHS/OASH does not determine your organization’s authorizing official; your organization makes that designation. For information on registering for Grants.gov, refer to http://www.grants.gov or contact the Grants.gov

Contact Center 24 hours a day, 7 days a week (excluding Federal holidays) at 1-800-518-4726 or support@grants.gov.

Your organization is strongly encouraged to register multiple authorized organization representatives in Grants.gov to ensure someone is available to submit your application.

2. Technical Assistance

A technical assistance webinar for potential applicants will be held on Thursday, June25, 2020 at 1:00 PM Eastern. Log-in information and additional details will be posted on the ORI website at ori.hhs.gov.

We recommend you review the entire announcement promptly so you can have any questions answered well in advance of the application due date. We also recommend you subscribe to this announcement in Grants.gov so you receive any amendments, question and answer documents, or other updates.

B. PROGRAM DESCRIPTION:

The Office of the Assistant Secretary for Health, Office of Research Integrity announces the availability of funds for Fiscal Year (FY) 2020 grant awards under the authority of Sec. 301 of the Public Health Service Act, 42 U.S.C. § 241, as delegated to the Director of ORI.

http://www.grants.gov/ mailto:support@grants.gov https://ori.hhs.gov/

1. Scope of Conferences

Research institutions receiving funding from any of the Public Health Service agencies 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). Conferences or workshops must be designed to provide a forum for discussion and produce tangible outcomes related to at least one of the following themes: 1)

Responsible Conduct of Research (RCR) training; 2) fostering an environment that promotes research integrity; 3) prevention of research misconduct; 4) effective handling of research misconduct allegations; 5) whistleblowing and protection of whistleblowers; or, 6) other topics linked to research integrity and compliance with 42 C.F.R. Part 93. Virtual conferences, and workshops will be eligible for funding.

2. Conference Objectives

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 awardee. Per 45 C.F.R. § 75.432, “conference 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. To ensure optimal utilization of ORI’s support, applicants should articulate a comprehensive evaluation strategy that incorporates validated measures and techniques and encompasses retention and application of knowledge gained through the conference, including post-conference evaluation.

ORI intends this initiative to provide a mechanism for those concerned with research integrity to meet to discuss theoretical, empirical, research design, educational, legal, procedural, ethical, and other issues related to preventing research misconduct and addressing issues that arise after an allegation of research misconduct is brought forward at an institution. Applicants should design their meeting to bring together experts from diverse areas of research, education, administration, law, and government to develop new tools for education and design programs to help prevent research misconduct and promote research integrity. The proposed events should produce measurable outcomes, as demonstrated through retention and application of knowledge gained, which may be assessed through post-evaluation data or other appropriate means.

To meet the aims outlined in this funding opportunity, ORI encourages conferences in the following areas. The list is not exhaustive nor is it presented in order of importance. Proposed conferences should be non-duplicative and substantially distinct from existing ORI activities.

Possible topic areas include:

• Identifying best practices for the research integrity community pertaining to the processes for conducting institutional research misconduct proceedings, including evidence sequestration, interviewing techniques and preparation, defining scope of the research record pertinent to the allegation, admissibility of evidence, and protection of whistleblowers and prevention of retaliation at an institutional level.

• Developing an ethical decision-making framework for research investigators that can be used as part of education programs focused on the responsible conduct of research.

• Convening experts from diverse disciplines who are able to apply innovative, established, emerging, or promising models to develop interventions to prevent or deter research misconduct. 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 (e.g., amplify dissemination or diffusion, build coalitions).

• Proposing strategies, approaches, and changes to institutional processes and practices to encourage witnesses and bystanders to potential research misconduct or questionable research practices ([QRPs], e.g. disruptions of power dynamics, p-value “hacking,” ghost authorship), to lodge good-faith reports with an appropriate institutional official.

Exploration of institutional factors, including institutional norms and culture, that might serve to deter whistleblowing, and practical solutions to help mitigate these barriers, are of particular interest.

• Developing networks to enable institutions to share and leverage knowledge and resources for handling allegations of research misconduct and QRPs.

• Developing networks and recommendations for implementing programs designed to facilitate compliance with federal and institutional requirements for training in the responsible conduct of research, considering evidence-based assessment of current practices, overarching theories, and incentives for fostering an environment that promotes research integrity.

Conference grant applications should include plans, including timelines, for disseminating conference materials and products beyond the participants attending the event. Although publications in peer-reviewed journals are encouraged, applicants must describe strategies for broad, multichannel dissemination of materials and key knowledge resulting from the conference.

This dissemination plan should articulate specific plans to amplify the reach, and ultimately the diffusion, of key points and materials that emerge from the conference. Applicants are encouraged to consider professional-quality imaging of at least one core element of the conference (e.g., plenary or keynote address) that will be made available to the public via a publicly available website.

C. AUTHORITY

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

D. FEDERAL AWARD INFORMATION

The Office of Research Integrity intends to make funds available for competing grants. We will fund awards in full (one budget period) and generally for a project period up to 1 year, although we may approve shorter project periods. Budget periods may also vary from the estimate indicated below due to timing of award issuance or other administrative factors.

Award Information

Estimated Federal Funds Available: $100,000

Anticipated Number of Awards: 2-4

Award Ceiling (Federal Funds including indirect costs): $50,000 per budget period

Award Floor (Federal Funds including indirect costs): $25,000 per budget period

Anticipated Start Date: September 30, 2020

Estimated Period of Performance: Not to exceed 1 year

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

E. ELIGIBILITY INFORMATION

1. Eligible Applicants.

Any public or private entity, including faith-based, community-based, and Indian Tribes or

Tribal organizations, are eligible to apply.

Foreign institutions (non-domestic U.S.) entities and foreign components of U.S.

organizations are eligible to apply.

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget.

3. Application Disqualification Criteria

If you successfully submit an application, we will screen it to ensure it meets the below requirements. 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 www.grants.gov

(unless an exemption was granted 2 business days prior to the deadline) by the date and time indicated in the DATES section (A.1) of this announcement.

(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) HHS/OASH/GAM deems your application eligible according to section

E.1 Eligible Applicants.

(d) You must complete the required forms in the application package: SF-424, SF-424A, SF-424B, SF-LLL, and Project Abstract Summary.

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

(f) Your Project Narrative must not exceed 18 pages. NOTE: The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-424B, SF-LLL, Project Abstract Summary, and

Budget Narrative (including budget tables).

http://www.grants.gov/

(g) Your total application, including the Project Narrative plus Appendices, must not exceed 60 pages. NOTE: items listed in “(f)” immediately above do not count toward total page limit.

(h) Your Federal funds request including indirect costs must not exceed the maximum indicated in Award Ceiling.

(i) Your Federal funds request including indirect costs must not be below the minimum indicated in Award Floor.

F. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at http://www.grants.gov/. You can find it by searching on the CFDA number shown on page 2 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

OASH Grants and Acquisitions Management

Phone: 240-453-8822

Email: 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.

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section E.3. The page limit does mailto:OASH_Grants@hhs.gov not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria. 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 when printed on 8.5” X 11” paper by

HHS/OASH/GAM, we will not review it. 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 F.3.d, under the heading “Appendices” in the Application Content section of this funding opportunity announcement. Your documents should be easy to read. You should use the same formatting specified for the Project Narrative. However, documents such as résumés/CVs/biographical sketches, organizational charts, tables, or letters of commitment may use formatting common to those documents, but the pages must be easy to read. The NIH biographic sketch format is permissible (https://grants.nih.gov/grants/forms/biosketch.htm). 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. If your project is funded, HHS may publish information from your form; therefore, do not include sensitive or proprietary information.

https://grants.nih.gov/grants/forms/biosketch.htm

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. Your project narrative should include the following components:

1) Project Description

You should provide a clear and concise description of the conference you propose to address the need identified in the program announcement. ORI expects applicants to explain the rationale for proposing a particular conference and to present a clear connection between identified research integrity gaps and needs and the proposed activities. Proposals should detail the nature of the activities to be undertaken, how they address identified research integrity gaps and identified issues, and how they will assist in achieving the overall project goals and objectives. You should articulate why these specific activities were selected (e.g., has the approach been successful in other settings? Does the research suggest this direction?). You should also note any major barriers you anticipate encountering and how your project will be able to overcome those barriers. If a non-U.S. location is proposed, you should also justify the selection of that non-U.S. location.

Applicants should:

(a) Define the problems or issues on which the conference will focus.

Indicate if these are primarily national (U.S.) or international problems or issues.

(b) Describe the scope and breadth of the problems or issues on which the conference will focus.

(c) Indicate how the proposed conference will contribute to addressing the problems or issues nationally/internationally.

(d) Describe how you will advertise the conference and encourage attendance and to what extent technology will play a role, if applicable.

(e) Describe the training or technical assistance the conference will provide in the topic area, if applicable.

(f) Describe the composition of potential subrecipients who are intended to be involved in completing specific tasks, and identify the percentage of level of effort subrecipients are anticipated to provide in completing programmatic activities.

(g) Provide specifics about the proposed conference agenda, venue, speakers, attendees, materials, dissemination and follow-up strategies, expected outcomes, and approaches to overcoming possible barriers. You should include the number of expected attendees. If a non-U.S. location is proposed, you must include an estimate of how many people may travel from the U.S. to the conference for any role.

2) Outcomes

You should clearly identify the measurable outcome(s) that are anticipated to result from the project. HHS/OASH will not fund any project that does not include measurable outcomes. In addition to discussion in the narrative, applicants must describe how they envision the project will benefit the field at large.

A “measurable outcome” is an observable end-result that describes how a particular activity or event benefits the intended audience. It demonstrates the “impact” of the activity or event. For example, a change in knowledge, skill, attitude, awareness, or behavior about the subject matter as a result of one or more components of the activity or event. This may include new knowledge or a measurable increase in institutional awareness. A measurable outcome is not a measurable “output,” such as the number of participants, the number of training sessions held, or the number of lectures provided. These numbers in combination with other measures may contribute to the overall evaluation of the activity or event.

You should keep the focus of this section on describing what outcome(s) will be produced by the project. You should use the Evaluation section noted below to describe how the outcome(s) will be measured and reported. Your application will be scored on the clarity and nature of your proposed outcomes, not on the number of outcomes cited. 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.

3) Project Management

You should include a clear delineation of the roles and responsibilities of project staff and subrecipients and how they will contribute to achieving the project’s objectives and outcomes. It should 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 other partners and HHS/OASH. It should also describe the approach that will be used to monitor and track progress on the project’s tasks and objectives. HHS/OASH expects that, throughout the grant period, the Project Director will have involvement in, and substantial knowledge about, all aspects of the project.

4) Evaluation

You should describe the methods that you will use to evaluate whether or not the proposed conference achieves its measurable outcome(s) and assess and evaluate the impact of the proposed activities. You should describe the quantitative and qualitative tools and techniques that you will employ to measure the outcome(s) and how you will identify and document the “lessons learned.”

You should also 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. You should also describe how you will collect and report any output measure data with respect to validity and reliability.

5) Dissemination

You should describe your dissemination plan and the role, if any, that technology will play in it. You should 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 target audience, the general public, and other parties who might be interested in using the results of the project. Although publications in peer-reviewed journals are highly valued, applicants should describe strategies for broad, multichannel dissemination of materials and key knowledge that emerge from the conference. All appropriate findings and products will be posted on a HHS/OASH sponsored website as determined by the HHS/OASH program officer. Therefore, applicants should propose other innovative approaches to informing parties who might be interested in using the results of the project to inform practice, program development, and/or policy-making, especially to those parties who would be interested in replicating the project. HHS/OASH expects that nationwide/international dissemination of products and knowledge will occur. Applicants should discuss the degree to which key points and materials that emerge from conference events and activities will be disseminated, and describe plans to amplify the reach of their efforts.

6) Innovation

You should describe any novel approaches or methods you intend to employ to fulfill the conference’s purpose. You should reference existing approaches for the purpose of contrasting the novel approaches or methods you propose. In cases in which the proposed conference will address an underdeveloped topic area (e.g., clinical research ethics) utilizing approaches or methods that do not diverge substantially from existing practices, describe the novelty in the application of those methods to the topic. You should describe how the conference will draw together appropriate experts who may otherwise not have an opportunity to meet.

7) Environment and Organizational Capability

You should describe the proposed conference site and articulate the characteristics or features of the site that make it an appropriate setting for conference activities. You should describe how the applicant organization (or the particular division of a larger agency that will have responsibility for this project) is organized, the nature and scope of its work, and the capabilities it possesses. This description should cover capabilities of the applicant agency 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 organizational chart showing the relationship of the project to the current organization.

Also 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. Applicants may forge collaborations and seek matching funds to support conference activities. Collaborations should be described in the application and in accompanying letters of commitment. Voluntary cost-sharing or matching (monetary or in-kind support) will not be used as a factor during the merit review of applications. Collaborations should be described in the application and in 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. You must indicate the method you are selecting for your indirect cost rate. See Indirect Costs below for further information.

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).

Please be sure to carefully review section F.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 proposed project. Provide a budget justification, which includes explanatory text and line-item detail, for the 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.

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. For example, if you are proposing to provide services to clients, you should describe how many clients are you expecting 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 (when required) must be detailed and justified in the budget narrative. "Federal resources" refers only to the HHS/OASH funds for which you are applying. "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

Note, subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items, i.e., subrecipient travel should be included in the Contractual line item not in Travel.

1) Object Class Descriptions and Required Justifications

(a) Personnel Description

Costs of staff salaries and wages, excluding benefits.

(b) Personnel Justification

Clearly identify the project director or principal investigator, 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.6 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.

(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.

(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. (Note: 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.

Note: Whenever you intend to delegate part of the project to another agency, you must provide a detailed budget and budget narrative for each subrecipient/contractor, by agency title, 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 delegated, the estimated costs, and the process for selecting the delegate agency.

(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.

• 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.”

This 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.

(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. If you have multiple approved rates, indicate which rate as described in your approved agreement is being applied and why that rate is being used. For example, if you have both on-campus and off-campus rates, identify which is being used and why.

(q) Program Income Description

Program income means gross income earned by your organization that is directly generated by this project if funded except as provided in 45 C.F.R. § 75.307(f). Program income includes but is not limited to income from fees for services performed or the use or rental of real or personal property acquired under the award. Interest earned on advances of Federal funds is not program income. Except as otherwise provided in Federal statutes, regulations, or the terms and conditions of the Federal award, program income does not include rebates, credits, discounts, and interest earned on any of them. See also 45 C.F.R. §§ 75.307, 75.407 and 35 U.S.C. §§ 200-212 (applies to inventions made under Federal awards).

(r) Program Income Justification

Describe and estimate the sources and amounts of program income that this project may generate if funded. Unless being used for cost sharing, if applicable, these funds should not be added to your budget. This amount should be reflected in box 7 of the SF-424A.

(s) Non-Federal Resources Description

Amounts of non-federal resources that will be used to support the project as identified in box 18 of the SF-424. For all federal awards, any shared costs or matching funds and all contributions, including cash and third-party in-kind contributions, must be accepted as part of the recipient’s cost sharing or matching when such contributions meet all of the criteria listed in

45 C.F.R. § 75.306. For awards that require matching by statute, you will be held accountable for projected commitments of non-federal resources in your application budgets and budget justifications by budget period or by project period for fully-funded awards, even if the justification by budget period, or by project period for fully-funded awards, exceeds the amount required. Your failure to provide the required matching amount may result in the disallowance of federal funds.

If you are funded, you will be required to report these funds on your Federal Financial Reports.

For awards that do not require matching or cost sharing by statute or regulation, where “cost sharing” refers to costs of a project in addition to Federal funds requested that you voluntarily propose in your budget, if your application is successful, we will include this non-federal cost sharing in the approved project budget and you will be held accountable for the non-federal cost-sharing funds as shown in the Notice of Award (NOA). Your failure to provide voluntary cost sharing of non-federal resources that have been accepted by HHS/OASH as part of the approved project costs and that are shown as part of the approved project budget in the NOA may result in the disallowance of federal funds. If you are funded, you will be required to report these funds on your Federal Financial Reports. Note, you will not receive any preference, priority, or special consideration in the funding process for voluntarily including non-Federal cost sharing in your proposed budget.

(t) Non-federal Resources Justification

You must provide detailed budget information for every funding source identified in box

18. "Estimated Funding ($)" on the SF-424. Provide this documentation as part of your Budget

Narrative file, not your Appendices.

You must fully identify and document in your application the specific costs or contributions you propose in order to meet a matching requirement. You must provide documentation in your application on the sources of funding or contribution(s). In-kind contributions must be accompanied by a justification of how the stated valuation was determined. Matching or cost sharing must be documented by budget period (or by project period for fully-funded awards). If your application does not include the required supporting documentation for a matching requirement, it will not be disqualified from competitive review; however, it may impact your score under the evaluation criteria in Section G.1 of this announcement.

2) Plan for 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 Office of Grants Management and Payment Management Services as well as timely and appropriate withdrawal of cash from the Payment Management System.

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.

1) Work Plan

Your Work Plan should reflect, and be consistent with, the Project Narrative and Budget

Narrative, and must cover the entire project period. Your Work Plan should include a statement of the project’s overall goal, anticipated outcome(s), key objectives, and the major tasks, action steps, or products that will be pursued or developed to achieve the goal and outcome(s). For each major task of each year, action step, or product, your work plan should identify the timeframes involved (including start- and end-dates), and the lead person responsible for completing the task.

2) Responsible Conduct of Research Plan

You should describe plans to ensure that all personnel involved in the project have acquired training in the responsible conduct of research. This includes, but is not limited to, training in the pertinent federal, state, and local regulations (conflicts of interests, use of human subjects, research misconduct) and institutional policies (authorship and publication, data management, peer review, and research collaborations) relevant to the proposed conference.

3) Letters of Commitment from Subrecipient Organizations, Consultants and

Agencies

You may include signed Letters of Commitment for all organizations, consultants and entities that have been specifically named as a subrecipient to carry out any aspect of the project.

Signed letters of commitment may be required prior to the making of an award. The signed letters of commitment must detail the specific role and resources that will be provided, or activities that will be undertaken, in support of the applicant. The organization or person’s expertise, experience, and access to the targeted population(s) should also be described in the letter of commitment.

Letters of commitment are not the same as letters of support. Letters of support are letters that are general in nature that 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 such as this will not be considered during the review.

4) Curricula Vitae/Résumés/Biographical Sketches for Key Project

Personnel

You must submit with your application curricula vitae and/or résumés and/or biographical sketches of the Project Director/Principal Investigator and all other Key Personnel.

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 your organization’s program. This includes at a minimum, the Project

Director/Principal Investigator. We encourage individuals to use their full name (first, middle, last) on these documents to distinguish them for verification in the System for Award

Management exclusion records. Omission of a middle name or initial may delay the award of an approved application. You should use the formatting common to those documents (See https://grants.nih.gov/grants/forms/biosketch.htm for templates and sample biographical sketches).

5) Description of Facilities and Resources Available

Describe how the environment in which the conference will be held contributes to the probability of success (e.g., institutional support, physical resources, geographic location, intellectual rapport). In describing the environment in which the work will be done, discuss ways in which the conference will benefit from unique features of the environment or from unique audiences or how activities will employ useful collaborative arrangements. If there are multiple performance sites, describe the resources available at each site.

6) Citations of References Cited in Program Narrative

Use a citation format of your choice. We do not require a specific citation format but request consistency throughout the application. Most style guides include format guidance for citations.

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

You are required to provide a Dun and Bradstreet (D&B) Data Universal Numbering

System (DUNS) number when applying for Federal awards through Grants.gov. It is a unique, nine-digit identification number, which provides unique identifiers of single business entities. The

DUNS number is free and easy to obtain. If you do not currently have a DUNS number, please contact Grants.gov to create a temporary DUNS number if you are unable to complete the SAM registration process prior to submitting your application.

https://grants.nih.gov/grants/forms/biosketch.htm

You will find instructions on the Grants.Gov web site as part of the organization registration process at http://www.grants.gov/web/grants/applicants/organization-registration.html.

Your organization must register online in the System for Award Management (SAM).

Under normal operating procedures Grants.gov will reject submissions from applicants with nonexistent or expired SAM Registrations. Because of the public health emergency with COVID-

19, the requirement for SAM registration at the time of submission has been waived. A completed registration in SAM may be required prior to receiving any award based on your application.

If you are…