Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Since 1997, the National Institutes of Health (NIH) has dramatically increased its funding of research and research capacity-building in low- and middle-income countries (LMICs). To help NIAID foreign research partners successfully manage grants and cooperative agreements, regional post-award grants policy and management training workshops are held annually. The National Institute of Allergy and infectious Diseases (NIAID) hosts three-day, regional post-award grants management training workshops in countries where institutions receive NIAID research funding. The objective is to help senior administrators better understand NIAID/NIH funding policies and Department of Health and Human Services (DHHS) regulations.

While these regional post-award grants policy and management training workshops have helped many attendees, they are brief, and often the cost of travel prohibits some institutions from participating. This notice of funding opportunity (NOFO) will enable senior administrators from LMICs to receive advanced training in NIH grants policy and financial management of grants, including compliance with NIH scientific reporting requirements. For this NOFO a senior administrator is defined as institutional staff with responsibility for grants administration, including business officials, grants managers and researchers with administrative responsibilities.

Purpose and Scope

The purpose of this NOFO is to encourage submission of applications from research institutions in World Bank designated LMICs, to provide senior administrators with advanced training in the management of NIAID/NIH grants with the goal of improving oversight of NIAID awards and compliance with NIH funding policies and federal research requirements. The overall intent of the initiative is to support the training of senior administrators and empower them to serve as institutional grants management leaders; provide them with access to best practices for managing awards; assist administrative staff in developing, enhancing, and/or implementing standard operating procedures (SOPs) for tracking grant expenditures and complying with NIH funding and compliance policies; and assist or train other administrators within the region. Along with senior foreign business officials receiving hands-on training from more experienced U.S. partnering institutions, applicant institutions are expected to provide train-the-trainer types of opportunities for institutional business officials and senior foreign business officials throughout the region.

An additional goal of the NOFO is to support a long-term plan that will result in organizational change to improve grants administration at the recipient institution. NIAID expects the applicant institution to initiate new or revised grants administration processes and collect relevant data to demonstrate the importance of developing or strengthening grants management activities that can help to maintain institutional competitiveness and/or the efficiency and productivity of research administration operations. The applicant institution is expected to initiate research grants administration enhancements and/or innovations during the grant funding period with the potential to continue after the funding has ended that will enhance faculty effectiveness in competing for NIAID research funding, address key barriers to faculty participation in research, and promote the development of an enabling research environment. Examples include, but are not limited to, development of SOPs that include specific steps for effectively managing sponsored research funds within the local institution; the development of a new in-house, grants management career track for business management trainees or college students; the development of processes and/or work tools and systems that need to be developed, facilitated, and/or acquired to address gaps in existing pre- and/or post-award processes; and identification and development of services that support faculty members with an interest in developing externally sponsored research programs.

This NOFO will provide support for travel of at least two senior administrator(s) from the LMIC institution to a more experienced partnering U.S. host institution where they will receive hands-on training in grants administration. At least two senior administrators from the applicant institution are expected to attend a NIAID post-award grants policy and management training event or other NIH Regional Seminar virtually or in-person during the lifetime of the award. This training will allow NIAID/NIH staff to provide customized information about managing NIAID awards, as well as tailored hands-on training based on the needs of participating institutions.

Training models appropriate for the context of the LMIC institution are highly encouraged. Training should take place at the most appropriate site. The training site may be virtual and/or may include institutions other than the applicant institution or LMIC institution(s) named in the application, including sites within high-income countries.

Applications that do not include all the following plans and letters of support will be considered not responsive and will be withdrawn before review:

• Research Grants Administration/Financial Management Plan
• Staff Training Plan
• Long-term Plan
• 3 Letters of Recommendation
• One Institutional Commitment Letter
• One U.S. Institutional Commitment Letter

Applicants are encouraged to review the NIAID questions and answers webpage https://www.niaid.nih.gov/grants-contracts/questions-and-answers-global-infectious-disease-research-administration.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Non-domestic (non-U.S.) Entities (Foreign Institutions)

At the time of submission, eligible applicant organizations must be in a LMIC, as defined by The World Bank, and include research institutions in LMICs.

Eligible applicant foreign institutions in LMICs are limited to those receiving NIAID grant and/or cooperative agreement support at the time of application submission.

Eligible organizations must have received no more than $8 million in total NIAID grant and/or cooperative agreement support in the last 5 years at the time of submission. To ensure that the U.S. host institutions have appropriate expertise in the management and administration of NIH grants, host institutions are limited to U.S. institutions that, at the time of submission, have received at least $5 million per year in total NIH research grant and/or cooperative agreement support over the last 10 years.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

PD/PI is a senior administrator with responsibility for grants administration (e.g., grants administrator, business official, and/or researcher with administrative responsibilities). A doctorate-level degree is not required to be the PD/PI.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ann-Marie Brighenti, Ph.D.
Telephone: 301-761-3100
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

• Include the biosketch of at least the PD(s)/PI(s) and one additional senior administrator to travel and receive training in the U.S. at the host institution. If a multiple PD(s)/PI(s) application, the contact PD/PI will be one of the senior administrators who travels to and receives training in the U.S.
• The biosketch of the proposed PD(s)/PI(s) should describe the qualifications and experience to serve as the senior administrator and to lead the proposed program, including relevant scientific or professional background, institutional responsibilities and authorities, qualifications, and relevant experience in LMICs. For the PD(s)/PI(s) a business degree or equivalent qualification is desirable, although not required.
• Include the biosketch of at least one person at each participating institution as senior/key personnel and identify their role.
• The biosketches of any additional senior administrator requesting support to travel and receive training should demonstrate sufficient institutional responsibilities and authority to develop and implement strategies for strengthening the research administration and support mechanisms at their home institution as well as administrative and professional leadership qualities to enhance and implement the training/mentoring.
• The biosketches of the key collaborator(s) at the partnering U.S. institution and the applicant institution should describe the relevant scientific or professional background and/or research training experience and their role in the ongoing administration of the proposed research training program.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

• Submit justification for the administrative, training or teaching responsibilities and time commitment for salaried foreign senior administrators. The salary requested for Senior/Key Person and Other Personnel must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described in the NIH Salary Cap Summary.
• Submit travel costs for key personnel (at least two including the PD/PI and senior administrator(s)) and travel for training responsibilities and to attend necessary meetings and/or workshops. PDs/PIs are expected to attend a NIAID post-award grants policy and management training event or other NIH Regional Seminar virtually or in-person during the lifetime of the award and may also budget for grant administrators to attend. Travel budget must not exceed $30k in direct costs per year. Support for Senior/Key personnel, faculty, and collaborators to attend meetings and conferences is not allowed.
• Submit a justification for the consulting fees by the U.S. host institution. Funds for the partnering U.S. host institutions will be limited to consultant fees at the host institution.
• Applications requesting funds to promote distance learning, including webinar training or videoconferencing may include $5000 of direct costs.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Briefly describe the specific aims of the proposed training program, including the overall goals, critical gaps in grants administration, objectives including the process for making sustainable business process changes, and how the program will meet the objectives outlined in this NOFO.

Research Strategy: Applicants are expected to describe their training strategy and implementation of related business processes and must include the following three plans:

Research Grants Administration/Financial Management Plan

• Describe the ways that the administrators trained under this award will support faculty researchers performing NIAID funded research within the context of the research grant life cycle (receipt of award, budget implementation, and managing grant awards).
• Describe the current grants administration/financial management process used at the applicant institution.
• Identify which aspects of the grants administration-related services the proposed Research Grants Administration/Financial Management Plan will address (i.e., post-award expenditure tracking, financial reporting, or other NIH funding and compliance requirements) and explain how the current administration/plan will be improved.
• Identify the partnering U.S. institution and describe how the PD/PI and host administrators/business officials will interact to achieve the training and business practice goals of the program.
• Describe prior and/or current research collaborations among the applicant institution and other proposed partnering institution(s) and how they serve as a foundation to support the proposed training. The list of collaborations may be submitted in a table format.
• Describe how the institution leadership and relevant participating collaborators were involved in the development of the application.
• Describe the overall strategy and methodology to be used to accomplish the specific aims and include a timeline for the Research Grants Administration/Financial Management Plan.
• Outline the processes and work tools that will be developed and/or acquired to address gaps in existing research grants administration support services (i.e., pre-award services, post-award services, compliance, preparation for Federal funding related audits etc.).
• Indicate how the proposed program of activities will be integrated into the institution's grants management functions.
• Describe how the plans for research grants administration and the training of local grants administrators adequately identify specific needs within the applicant's existing research grants administration, establish reasonable specific aims, as well as identify best practices (i.e., interventions, work tools, and processes) that can effectively address and eliminate targeted deficiencies and gaps.

Staff Training Plan

• Describe the plans for mentoring and development of junior grants management staff. The staff training plan should include a viable plan, based on allowable activities at the local institution, for senior grants management staff to train current and future institutional grants management leaders; essentially a "Train-the-Trainer" plan.
• Describe the plans to include grants management training opportunities or expertise that will be made available to other institutions that receive NIAID/NIH funding in the local area.
• For applicants that plan to provide training to other local in-country institutions, describe how this activity will be developed and executed.
• Describe the immediate and long-term objectives of the training plan, including information about curricula, workshops, and/or other training opportunities that will be available through the proposed project.

Long-term Plan

• Applicants should describe plans and procedures to develop and implement (including a timeline for the long-term plan) grants management or related best business practices that could continue after the grant funding period ends. A long-term plan may include the development of a grants management training program at the college level to ensure a pipeline of grants management specialists, establishing an institutional sponsored research program office, or other activities that may result in sustainable changes. Applicants must describe the long-term plan, as well as how and when it will be implemented.
• Describe the level of authority needed within the institute to implement and maintain grants management changes that result from the long-term plan. Indicate who has the authority and whether that person or entity has agreed to make changes, if needed.

Letters of Support: Applicants must provide the following letters of support. Applications that do not include the following letters will be considered non-responsive and will be withdrawn before review:

Letters of recommendation: Applicants must provide three letters of support from colleagues who have worked with the PD/PI and/or have the knowledge to describe and comment on PD/PI’s role in grants administration, effectiveness in working with a team and ability to successfully communicate and coordinate across organizational boundaries. Each letter must also include the referee's name, title, institutional affiliation, address, telephone and fax numbers, and email address.

Institutional Commitment Letter: A letter of commitment must be provided by the President or designated high-ranking official (i.e., Provost, Vice-President for Research, Dean, etc.) of the LMIC Institution as evidence of institutional commitment to enhancing research grants administration. The letter should highlight the provision of adequate staff, facilities, authority to implement changes to the grants management process and resources that can contribute to the planned efforts to improve training in research grants administration. It should also include a commitment to the proposed long-term plan project described in the application. In addition, the letter should affirm that the applicant institution has current NIAID funding and include the grant number(s) and total amount in U.S. dollars for all NIH grant and/or cooperative agreement support received in the last 5 years at the time of application submission.

U.S. Institutional Commitment Letter: A letter of commitment must be provided by the business office of the U.S. institution as evidence of institutional commitment to provide at least two grants management best practices training sessions at their institution. It should also include a commitment to provide one senior grants manager with NIH grants management experience to oversee the two grants management training events, and to review the grantees proposed local grants management/business plans. The letter should affirm that the U.S. host institution, at the time of submission, has received at least $5 million per year in total NIH research grant and/or cooperative agreement support each year over the last 10 years.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIAID, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important grants management or oversight problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will knowledge, technical capability, and/or grants administration practices be improved? How will successful completion of the aims change the concepts, methods, technologies, or services that drive this field?

Specific to this NOFO: How well justified is the proposed project in terms of addressing deficiencies or gaps in the existing research grants administration/financial management infrastructure? To what extent are processes and/or work tools identified that need to be developed, facilitated, or acquired to address current gaps in the infrastructure? How well does the staff training plan facilitate the strengthening of grants administration at the grantee institution and, where proposed, other in-country institutions?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other research administrators (or researcher with significant grants administration responsibilities) well suited to the project? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this NOFO: To what extent does the PD/PI or senior grants manager (if not the PD/PI) have the ability to provide administrative leadership and direction for the project? To what extent has PD/PI demonstrated the ability to perform in a team environment to accomplish objectives that require coordination across multiple organizational entities? To what extent does the PD/PI have the requisite authority to implement the proposed institutional grants administration/management training plan? How appropriate are the skills and experience levels of the PD/PI and/or senior grants manager? To what extent does the PD/PI or senior grants manager have sufficient authority and/or relative areas of responsibility to implement research grants administrative changes?

To what extent does the U.S. host institution have appropriate skills and experience in managing NIH awards to train a foreign senior administrator(s)? How adequate is the plan for communication between the U.S. host institution and the foreign senior grants manager(s)?

Innovation

Does the application challenge and seek to shift current research grants administration paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of grants management or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Do the plans for research grants administration and the training of local grants administrators adequately identify specific needs within the applicant's existing research grants administration, establish reasonable specific aims, as well as identify best practices (i.e., interventions, work tools, and processes) that can effectively address and eliminate targeted deficiencies and gaps? Are the plans for mentoring junior grants management staff and providing competency-based training in grants administration adequate? As needed, is there a well-reasoned plan for institutional grants management practice changes? If applicable, are plans sufficient for training grants specialists at other in-country institutions that manage NIH awards? Is implementation of the sustainability initiative appropriate? Are the goals for sustained management of NIH awards after the project funding has ended reasonable?

Specific to this NOFO: How well do the plans for research grants administration and the training of local grants administrators adequately identify specific needs within the applicant's existing research grants administration, establish reasonable specific aims, as well as identify best practices (i.e., interventions, work tools, and processes) that can effectively address and eliminate targeted deficiencies and gaps? How adequate are the plans for mentoring junior grants management staff and providing competency-based training in grants administration? As needed, is there and how well-reasoned is the plan for institutional grants management practice changes? If applicable, how sufficient are plans for training grants specialists at other in-country institutions that manage NIH awards? How appropriate is the implementation of the long-term plan? How reasonable are the goals for sustained management of NIH awards after the project funding has ended?

Environment

Will the administrative environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the administrators adequate for the project proposed? Will the project benefit from unique features of the scientific and business environment, subject populations, or collaborative arrangements?

Specific to this NOFO:

To what extent does the applicant's high-level leadership exhibit strong support for strengthening the institution's research administration training capability?

How well does the LMIC Institutional commitment reflect the provision of adequate staff, facilities, training, and resources that can contribute to the planned efforts to improve training in research grants administration?

To what extent are the requested resources appropriate based on the goals of the institution's long-term plan?

To what extent does the U.S. host institution have the appropriate grants management staff and environment to adequately train a foreign senior grants manager? How appropriate is the site for training in the U.S.?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Please bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Please bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Please bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Please bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Not Applicable

Resource Sharing Plans

Not Applicable

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

1. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

An Evaluation Plan is required. At the end of 12 months of the award period, recipients must submit a strategy for improving grants management oversight and business practices at their institution. The U.S. host institution must sign-off on the draft. By the end of the 24 months award period, the recipient must provide a report that states what changes have been initiated or made to the local business practices of the recipient and staff training plan. The host institution must sign the report.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Madelyn Reyes, DNP, FAAN
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301- 594-5945
Email: [email protected]

Ann-Marie Brighenti, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-3100
Email: [email protected]

Nicole Guidetti, MS
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6934
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.