PKG00262076-instructions.pdf

DEPARTMENT OF

HEALTH AND HUMAN SERVICES

OFFICE OF THE

ASSISTANT SECRETARY FOR HEALTH

Office of Research Integrity

Funding Opportunity: IR-ORI-20-001

Opportunity Number: 93.085

Application Due Date:

August 4, 2020 at 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 Research on Research Integrity

ACTION

Notice

ANNOUNCEMENT TYPE

Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER

IR-ORI-20-001

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 Monday, June 22, 2020 at 1:00 PM Eastern.

EXECUTIVE SUMMARY

The Office of Research Integrity (ORI) 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.

This notice solicits applications for projects that will conduct innovative original research related to the prevention of research misconduct, facilitation of whistleblowing and the protection of whistleblowers, and promote the responsible conduct of research and the furtherance of research integrity in the United States and internationally.

The goal of the program is to develop the evidence base for the research integrity community to create or enhance educational and interventional programs for promoting research integrity and preventing research misconduct. ORI specifically seeks to support innovative research to (a) identify risk factors at the individual, group (laboratory or department), and institutional levels that lead to questionable research practices (QRPs) and research misconduct, and resilience factors at the individual, group, and institutional levels that make involvement in research misconduct and QRPs less likely, and (b) examine the effectiveness of approaches for deterring research misconduct and facilitating the handling of research misconduct allegations, including the identification of factors or circumstances that facilitate or deter whistleblowing and that shield whistleblowers from negative consequences.

This funding opportunity does not support projects with the primary purpose to hold meetings, conferences, or to develop and evaluate programs, resources, or assessment tools. ORI anticipates that the Research on Research Integrity awards will have a ceiling of up to $150,000

(direct and indirect funding) with a floor of $50,000 for a project period of up to 12 months. ORI anticipates making up to ten awards.

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 relaxed. However, if you do not have mailto:ogm.oash@hhs.gov a DUNS number at this time, you should contact the 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.

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.

http://www.grants.gov/ mailto:support@grants.gov

2. Technical Assistance

A technical assistance webinar for potential applicants will be held on Monday, June 22, 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.

1. Background

ORI intends to foster innovative approaches for research on research integrity and preventing research misconduct through this announcement. For the purposes of this announcement, research integrity is defined as the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms of the research community.

The ORI Extramural Research Program has provided funding over the years to build and expand the evidence base to support the creation or enhancement of educational and intervention programs that promote research integrity and the responsible conduct of research (RCR) and https://ori.hhs.gov/ prevent research misconduct. This foundation of empirical evidence has led to the development of intervention programs, assessment tools, innovative training approaches, and tools for forensic analyses.

For this funding cycle, ORI specifically seeks to support innovative research to: (a) identify risk factors at the individual, group (laboratory or department), and institutional levels that may lead to research misconduct or questionable research practices (QRPs) and/or identify resilience factors at the individual, group (laboratory or department), and institutional levels that may prevent research misconduct and QRPs and promote research integrity; and (b) examine the effectiveness of approaches for deterring research misconduct and facilitating the effective handling of research misconduct allegations, including the identification of factors or circumstances that facilitate or deter whistleblowing and that shield whistleblowers from negative consequences.

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

2. Research Scope

Research institutions receiving funding from any of the HHS Public Health Service (PHS) 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” by 42 C.F.R. § 93.300(c). Research supported by this funding opportunity should address one or more aspects of this institutional obligation.

3. Research Objectives

To meet the aims outlined in this funding opportunity, research in the following areas is encouraged. This list is not exhaustive nor is it listed in order of importance.

a. Identifying Risk and Resilience Factors for Research Misconduct and QRPs

Researchers face numerous challenges and demands that may affect their performance and decision-making. Understanding these factors is important for identifying circumstances that contribute to involvement in research misconduct and QRPs.

Effective training and intervention programs targeted to researchers who may be vulnerable to the temptation to circumvent scientific best practices rely on valid and reliable evidence and rigorous testing. ORI is interested in risk factors at the individual, group (e.g., laboratory, department), and institutional levels, and how they interact within and across levels. Table 1 provides illustrative examples of potential risk factors at the individual, group, and institutional levels.

Table 1. Examples of risk factors at all levels of research within an institution

Individual Level Factors Group Level Factors Institutional Level Factors

• Job position (e.g., graduate student, postdoctoral researcher, staff researcher, adjunct, PI)

• Gender

• Age

• Ethnicity

• Stress and coping skills

• Financial pressures

• Tolerance to risk

• Socio-economic status

• Citizenship or immigration status

• Parental/family obligations

• Medical or health disabilities

• Lab size (i.e., number of personnel)

• Mentorship and supervision

• Pressure to publish

• Pressure to apply/receive funding

• Competition

• Norms of specific discipline

• Lab or departmental culture

• Peer pressure

• Hierarchy

• Lab and technology resources

• Tenure

• Academic culture

• Research culture

• Institutional reputation

• Institutional norms

• Institutional funding levels

• Institutional status

• Policies on research misconduct

• Policies on whistleblower support

• Policies on data management and storage

• Institutional staff training and resources

• Incentive structure

Little is known about resilience factors and how they affect the likelihood of involvement in research misconduct and QRPs. For this funding cycle, ORI encourages proposals for projects that identify risk and resilience factors for QRPs and research misconduct and investigate the interactions of these factors within and across levels.

Examples of research projects include but are not limited to:

• Studies that compare the perceived pressures between research trainees who are U.S.

citizens and those who are non-U.S. citizens. Foreign trainees must rely on work visas to remain in the U.S. and those differential pressures may combine with other factors, such as mentorship, lab culture, and the pressure to publish, to influence attitudes and behavior toward research misconduct and QRPs.

• Studies that investigate the departmental and institutional pressures and demands as perceived by principal investigators (PIs) and their ability to be effective mentors, their attitudes toward QRPs and research misconduct, and lab members’ perceptions of standards set by the PI.

• Studies that examine the effect of institutional research culture or policies on individuals’ willingness to report research misconduct or be a witness in research misconduct proceedings.

• Studies that explore factors (e.g., peer pressure, perceived self-efficacy, leadership) that can serve as either risk or resilience factors depending on the context, settings, or other elements, and therefore act to increase or decrease the odds of engagement in research misconduct and/or QRPs. These studies should endeavor to characterize putative pathways and mechanisms through which these factors might directly or indirectly (i.e., acting as moderators or mediators within a hypothesized pathway) affect the incidence and prevalence of research misconduct and QRPs.

• Studies that investigate the role of power dynamics, as well as disruptions of power dynamics, in facilitating or suppressing the occurrence of research misconduct or the timely reporting of research misconduct, either directly or indirectly.

• Studies that examine the role of institutional and departmental culture, programs, or policies on the quality and amount of mentorship, training, and supervision provided by PIs.

b. Identifying effective approaches for deterring research misconduct and facilitating the handling of research misconduct allegations

One of the goals of responsible conduct of research (RCR) training is to reduce the occurrence of research misconduct and QRPs. Relatively little research, however, has examined the effectiveness of RCR training or other interventions on preventing the occurrence of these undesired behaviors or the likelihood of reporting them.

ORI seeks to fund projects that investigate the effectiveness of various approaches for preventing or deterring research misconduct and facilitating the handling of research misconduct allegations. The identification of factors or circumstances that facilitate or deter whistleblowing and that shield whistleblowers from negative consequences is of particular interest to ORI at this time. This funding opportunity does not support projects that primarily develop new programs or the planning and staging of conferences, workshops, or meetings. Examples of desired projects include, but are not limited to:

• Studies that examine the amount and quality of supervision that will likely prevent or deter QRPs and research misconduct among graduate students, postdoctoral researchers, and early-career professionals.

• Studies that test the effectiveness of formal behavior change interventions designed to stop individuals from engaging in research misconduct. These interventions can include any combination of methods that have shown effectiveness in deterring people from engaging in prohibited behaviors. Studies of efficacy are acceptable when accompanied by comprehensive plans for effectiveness testing.

• Studies to investigate the effectiveness of different types or configurations of incentives

(individual and/or group) to encourage researchers at all levels of experience to avoid

QRPs and research misconduct, which could include image beautification, deleting or ignoring outliers, poor data labeling and collection, error estimation instead of calculation, and unreasonable imputation of missing data. Studies of efficacy are acceptable when accompanied by comprehensive plans for effectiveness testing.

• Studies to explore the utility of social and behavioral constructs and theories of behavior, related to factors at the individual, cultural, social and/or organizational levels, that might explain when and why individuals engage in research misconduct. These studies can focus on traditional perspectives or explore potentially new approaches based on unique circumstances that arise in research laboratories and other settings particular to the research enterprise such as consortia and geographically diffuse research groups. The research can use qualitative, quantitative, or mixed methods.

• Studies to test the efficacy of support programs for staff, students, postdoctoral researchers, early career professionals, and PIs who need assistance to avoid engaging in research misconduct. The programs tested require solid theoretical and empirical justifications and include ways to disseminate knowledge of and access to the program.

These support programs can include, but are not limited to, institutional, community or web-based interventions at local, regional or national levels. Interventions can include peer support, official institutional support, hotlines, web and mobile applications, or any other method that might encourage researchers tempted to engage in research misconduct or QRPs to seek help.

• Studies that examine various aspects of being a whistleblower, including assessment of factors that make it easier or more difficult for individuals to report potential misconduct within an institution, to a journal editor, or to ORI. Exploration of factors or circumstances that enable whistleblowers to continue to succeed and thrive, such as completion of doctorates, academic appointments, and similar achievements is of interest to ORI.

• Studies that examine the relationship between research misconduct and any among the full scope of QRPs, ranging from sexual harassment to ghost authorship to excessive self-citation, subverting objective peer review, and p-value hacking. Identification of specific

QRP risk factors that may lead to subsequent acts of misconduct is relevant. Studies should consider, when a relationship exists between the misconduct and risk factor(s), how to exploit that relationship as a possible intervention to mitigate or discourage misconduct.

• Studies that examine practices used by research institutions to provide adequate support staff and information technology resources and enables faculty to participate in research misconduct proceedings as subject matter experts. ORI seeks qualitative research that emphasizes what research institutions are doing well, how they can improve incentives and procedures to coordinate resources more effectively, and how to encourage faculty and staff to remain invested, empowered, and protected throughout a misconduct proceeding.

• Research studies that identify factors that make the process particularly difficult for, or deters involvement by, faculty and others in misconduct proceedings. ORI encourages complementary research that identifies factors that ease or incentivize involvement by faculty and others in misconduct proceedings.

• Studies that evaluate the effectiveness of one or both of the traditional means to prevent research misconduct and promote research integrity, namely RCR education and mentoring. Assessments of the impact of RCR education, mentoring, or both should focus on outcomes and evidence of improved behaviors, possibly along with attitudes and decision-making, rather than knowledge and awareness of rules and acceptable behaviors.

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 grant awards.

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: $700,000

Anticipated Number of Awards: 5-10

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

Award Floor (Federal Funds including indirect costs): $50,000 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 25 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).

(g) Your total application, including the Project Narrative plus Appendices, must not exceed 75 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 & 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 C. The page limit does 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 mailto:ogm.oash@hhs.gov 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. Overall, the Project Narrative should provide a clear and concise description of the research you are proposing.

Your project narrative should address the following content and be organized according to the following sections headings:

1) Significance

• Define the problem or critical barrier to progress in the field that the proposed project addresses.

• Describe the scope and breadth of the problem or critical barrier to progress in the field and potential effects on affected groups or populations (e.g., junior researchers, patients).

• Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.

• Explain how the proposed project will bridge gaps in the research and improve scientific knowledge, technical capability, and/or research practice in one or more research integrity fields.

• State concisely the goals of the proposed research and summarize the expected outcome(s), including the anticipated impact the results of the proposed research will exert on the research field(s) involved (e.g., test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm, address a critical barrier to progress in the field, or develop new technology).

• Describe how the concepts, methods, technologies, and educational strategies that drive this field will be changed if the proposed goals are achieved.

• If a non-U.S. location is proposed, you must justify the selection of this location.

2) Innovation

• Explain how the application challenges and seeks to shift current research integrity paradigms.

• Describe any novel theoretical concepts, approaches, methodologies, or interventions to be developed or used, and any advantage over existing methodologies or interventions these present.

• Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies or interventions.

3) Approach

• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted.

• List succinctly the specific, measurable, and time-framed objectives of the proposed project as they relate to the proposed research goals.

• Detail the nature of the activities to be undertaken, how they address identified research integrity gaps and identified issues, and a clear connection to how they will assist in achieving the proposed research goals.

• Articulate why the specific activities were selected (e.g., has this approach been successful in other settings? Does the research suggest this direction?).

• Note any major barriers you anticipate encountering in completing proposed activities and how your project will be able to overcome those barriers.

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

• If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

• If applicable, describe and justify the proposed involvement of human subjects (45

C.F.R. Part 46) in the work proposed by describing the following:

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

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

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

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

o How the records and/or data are collected, managed, and protected as well as whether material or data that include individually identifiable private information will be collected specifically for the proposed research project o Plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent.

o Circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. If a waiver of some or all of the elements of informed consent will be sought, provide justification for the waiver.

4) Project Management

• Identify the PI (or PIs), collaborators, and other researchers, including subrecipients, proposed for the project. Include a clear delineation of the roles and responsibilities of project staff and subrecipients and how they will contribute to achieving the project’s goals and outcomes.

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

• Describe a proposed plan 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 (42 C.F.R. part 93), 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 project.

5) Dissemination

• Describe a comprehensive dissemination plan to communicate key findings to stakeholders, the general public, and other parties who might be interested in the results of the proposed project. ORI expects that nationwide dissemination of products and knowledge will occur.

• Describe the methods you will use to disseminate the project’s results and findings in a timely manner and in easily understandable formats to the stakeholders, the general public, and other parties who might be interested in the results of the proposed project.

ORI may publish (including on a website), all appropriate findings and products.

Therefore, you should propose other, innovative approaches to inform parties interested in project results and how you will coordinate dissemination with potential partners to amplify the communication of those findings to stakeholders and other relevant parties.

6) Environment

• Describe the organizational capabilities of the applicant organization not included elsewhere in the program narrative, such as any current or previous relevant experience.

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

• Describe the scientific environment in which the work will be done and how it will contribute to the probability of success. This should include a description of the institutional support, equipment, and other physical resources available to the investigators. If there are multiple performance sites, describe the resources available at each site. Describe how the project will benefit from unique features of the scientific environment, subject populations, or collaborative arrangements.

• Identify the facilities you will use (e.g., computer lab, office, clinical setting). If appropriate, indicate their capacities, pertinent capabilities, relative proximity, and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work.

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 first year of 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.

a) 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.

b) 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).