Submission of Prior Approval Requests

NCATS grantees are required to adhere to the NIH Grants Policy Statement, unless the Notice of Award states otherwise.

All prior approval requests must be submitted in writing (including submission by email) to NCATSPriorApprovalRequest@mail.nih.gov with a copy to the named Grants Management Specialist (GMS) and Program Officer (PO) no later than 30 days before the proposed change and signed by the Authorized Organizational Representative.

We recommend grantees follow NIH guidance for the electronic submission of requests for administrative supplements and change of grantee organization:

• Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) (PA-20-272)
• Change of Recipient Organization (Type 7 Parent Clinical Trial Optional) (PA-21-268)
• Successor-in-Interest (Type 6 Parent Clinical Trial Optional) (PA-20-275)

See specific information about this guidance: 

• Change in Key Personnel
• Extensions
• Unobligated Funds/Carryover
• Foreign Components

Change in Key Personnel

Prior approval is only required for a change in effort for the PD/PI or other senior/key personnel specifically named in the Notice of Award.

Process for Submitting a Change in Key Personnel

NIH prior approval is required for any reduction of effort of 25 percent or more from the level that was approved at the time of the initial competing year award, or a change of 25 percent or more from a previously approved reduction in effort level as reflected in a revised Notice of Award.

All requests must be made via email to NCATSPriorApprovalRequest@mail.nih.gov with a copy to the GMS and PO assigned to the grant and signed by the Authorized Organization Representative (AOR) from the grantee institution. Requests should be submitted 30 days prior to the proposed change and must include the following information:

• Statement indicating the previous approved level of effort and the requested new level of effort reflected in person months
• Description of the remaining work that needs to be accomplished on the grant and statement that the requested level of effort is sufficient to complete the remaining work
• Justification for the change
• Statement indicating whether the change is related to concerns about safety and/or work environment (Refer to NOT-OD-20-124 for details)
• Start date for the change
• Budget changes resulting from the proposed change, if any
• Updated Other Support page, incorporating the requested change in effort, explaining how this change in effort affects the overall level of effort on other grants
• If a new individual is being added to the grant, a biographical sketch, current other support information, proposed effort level and certification of human subjects training (if applicable) is required for the proposed individual.
• If the change involves the reduction, addition or removal of a PI, signatures of the current PI/ PIs and the proposed replacement PI, if applicable, are required.

If all of the above documentation is provided, the review process should take no more than 30 days from receipt to notification of a decision.

Process for Submitting a Change in Multi-PD/PI

Multiple PD/PI awards are an opportunity for multidisciplinary efforts and collaboration through a team of scientists under a single grant award. All PD/PIs share equally the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant organization, or as appropriate to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI.

NIH prior approval is required for any change in multi-PD/PI including a change from a single PD and/or PI to a multiple PD and/or PI model and vice versa.

All requests must be made via email to the GMS and PO assigned to the grant and signed by the AOR from the grantee institution. Requests should be submitted 30 days prior to the proposed change and must include the following information:

• Statement indicating the previous approved level of effort and the requested new level of effort reflected in person months
• Description of the remaining work that needs to be accomplished on the grant and statement that the requested level of effort is sufficient to complete the remaining work
• Justification for the change
• Start date for the change
• Budget changes resulting from the proposed change, if any
• Updated Other Support page, incorporating the requested change in effort, explaining how this change in effort affects the overall level of effort on other grants
• If a new individual is being added to the grant, a biographical sketch, current other support information, proposed effort level and certification of human subjects training (if applicable) is required for the proposed individual.
• If the change involves the reduction, addition or removal of a PD and/or PI, signatures of the current PD and/or PIs, and the proposed replacement PD and/or PI, if applicable, are required.
• A revised multi-PD/PI Leadership Plan, including a conflict resolution plan

If all of the above documentation is provided, the review process should take no more than 30 days from receipt to notification of a decision.

Extensions

An extension is a request for additional time to complete an originally approved scope of work beyond the end date of the approved project period. An extension period should not be utilized to expand or increase the originally approved scope of work. NCATS currently considers First No-Cost Extensions, Subsequent No-Cost Extensions and Cost Extensions.

First No-Cost Extension

Within 90 days prior to the project period end date, grantees may extend the final budget period of the competitive segment one time for up to 12 months beyond the original expiration date shown in the Notice of Award via eRA Commons, if—

• No term of award or IMPAC II status specifically prohibits the extension;
• No additional funds are required to be obligated; and
• The project’s originally approved scope will not change.

If a grantee misses the deadline to submit a first no-cost extension in the Commons, the request should be submitted as a subsequent no-cost extension request, as described below.

Subsequent No-Cost Extension

Any additional project period extension requires NIH prior approval.

A second or third extension must be submitted via email by an AOR to NCATSPriorApprovalRequest@mail.nih.gov,with a copy to the GMS and PO at least 30 days before the end of the project period. The written request must include the following information:

• Amount of funds remaining (estimated unobligated balance), in U.S. dollars;
• Detailed budget reflecting the proposed plans to use the remaining funds during the extension;
• Level of effort for Key Personnel during the extended period (Reminder that for NIH awards, the PD/PI and other key personnel named in the Notice of Award must devote a measurable level of effort. Many NCATS grant programs include effort level requirements in the relevant funding opportunity announcements [FOAs].);
• Scientific rationale for continuing the project;
• Scope of work to be completed during the extension;
• Updated certifications and assurances, including institutional review board (IRB) and institutional animal care and use committee (IACUC) approvals;
• Detailed explanation of why the project could not be completed within the originally approved end date; and
• Explanation of how the project will be completed in this final extension or how it will proceed without additional funds.

NOTE: The fact that funds remain at the end of the project period is not sufficient justification for a subsequent extension.

NCATS rarely approves third extensions and does so only with extraordinary scientific justification and approval from the PD and Director, Division of Extramural Activities. If approved, this would be the FINAL extension for the grant.

Cost Extension (CE)

A cost extension is a one-time request for an extension of the original final budget period of a project with a minimal amount of funds, for a period of up to 12 months. The purpose of a cost extension is to provide an orderly completion/closeout of critical activities or a temporary continuation of support to prevent loss of research resources or hardship of personnel. Additional funding support is contingent on the availability of NCATS resources and funding.

To ensure a CE is the most appropriate path, PD/PIs are strongly encouraged to consult with their POs prior to initiating the CE prior approval process.

CE requests must be submitted at least 30 days before the original project period is scheduled to expire. Requests must be submitted electronically  in response to the NIH Parent Announcement for Administrative Supplements to Existing NIH Grants and Cooperative Agreements. A CE cannot be submitted if the recipient has not initiated their optional automatic first time No Cost Extension (NCE) via the Commons.  The NCE link becomes available 90-days before the project period ends. 

Prior to submitting a CE request, award recipients must ensure that the most current Federal Financial Report (FFR) has been submitted via the Payment Management System and accepted by NIH, and ensure the NCE has been initiated via the eRA Commons.

NOTE: NCATS will return any CE request if the most current FFR has not been submitted and accepted.

The CE request must include all the following information:

• Reason for request
• Amount of additional funds being requested
• Amount of time being requested (maximum period of up to 12 months)
• Amount of funds remaining (most current expenditure report listing direct and indirect costs), in U.S. dollars
• Detailed justification of why the current unobligated balance cannot be re-budgeted to cover requested costs
• Scientific rationale for continuing the project; ensure including the following, as applicable:
  • A detailed description of the scope of work to be performed during the extension
  • Orderly closeout plan
  • Project completion plan
  • Potential loss of research resources, including personnel
• Detailed budget and budget justification associated with proposed plans for parent and subaward sites; including the following:
  • Level of effort to be devoted by each staff member , as well as a detailed description of their role and responsibility during the orderly closeout phase
    • Identify any changes to key personnel
  • Detailed justification for any direct cost greater than $1,000
  • Facilities and administrative rate for parent and subaward sites
  • Checklist page for parent and subaward sites
• Updated Other Support for Key Personnel, if applicable
• Updated certifications and assurances, including IRB and IACUC approvals for completion of ongoing projects that involve human subjects or vertebrate animal subjects (NOTE: No new projects and/or research testing/methodologies may be initiated during the CE period.)
• Detailed sustainability plan describing how the program will continue without expectation of securing federal grant funds
• If requesting a CE in the final budget period, ensure that the AOR initiates a No-Cost Extension via the eRA Commons before the project period is scheduled to expire.

NOTE: No support or additional time may be requested for new activity and/or expansion of the currently approved scope of work. New and/or expanded activity would include, but is not limited to, new and/or additional scholar/trainee appointments, pilot projects, research methodologies, testing, etc.

NCATS will not approve requests if the primary purpose of the proposed extension is to permit the use of unobligated balances of funds or if the recompeting application for the currently funded award was submitted late and resulted in a lapse in grant support beyond a 12-month no-cost extension.

NCATS rarely approves subsequent cost extensions and does so ONLY in rare circumstances with extraordinary scientific justification.

NCATS will not consider a subsequent cost extension if the primary purpose is to stay afloat until future federal grant support is acquired.

Unobligated Funds/Carryover

Unobligated funds are appropriated funds that are unspent and/or uncommitted by the end of a budget period. Unobligated funds remaining at the end of a budget period may be used as carryover or offset by the federal government. Carryover is the process by which unobligated (unspent) funds remaining at the end of a budget period may be carried forward to a subsequent budget period to cover allowable costs in that budget period. An offset is the use of the unobligated funds to partially or fully fund a future budget period.

Prior Approval Requirements

Most grants have automatic carryover authority, meaning grantees do not have to request approval from NIH in order to carry over funds from one budget period to the next. Grantees that do not have automatic carryover authority are required to provide a written prior approval request to gain access to those funds. The following mechanisms typically do not have automatic carryover and require NIH prior approval:

• Cooperative Agreements (U)
• Program Centers (P30, P50, P60)
• Awards to Individuals, including Fellowships (F)
• Non-Fast-Track, Phase 1 (one-year) SBIR (R43) and (one-year) STTR (R41)
• Training Grants (T)
• Clinical Trials (regardless of activity code)

Before Submitting a Carryover Request

Prior to submitting a carryover request, the grantee is encouraged to discuss it with his or her PO and GMS. In addition, the grantee must ensure that the Federal Financial Report for the last (and all prior) budget period(s) have been submitted AND accepted by the NIH Office of Financial Management.

Process for Submitting a Carryover Request

Carryover requests must be limited to actual needs for the current budget period, must be expended before the end of the current budget period, must meet an immediate need and must not result in re-occurring costs.

All carryover requests must be made in writing (via email) to NCATSPriorApprovalRequest@mail.nih.gov with a copy to the GMS and PO assigned to the grant and signed by the AOR from the grantee institution. Requests must be submitted 30 days prior to the proposed use of the funds and must include the following information:

• Grant number and PI name
• Amount of funds to be carried over
• Explanation for the unobligated balance
• Plan for expenditure, including a description of activities to be carried out during the carryover period, and how the activities relate to the aims of the project
• Detailed budget and justification for all items, including detailed budget pages for any subcontract costs
• Clarification as to why current funding cannot be re-budgeted to cover the expenses.
• Identification of the requested Facilities and Administrative (F&A) costs, including F&A rate, for the prime grantee and any subcontracts
• Justification for the request (See below.)

When preparing a justification for a carryover request, grantees should answer the following questions:

• Why were the funds not spent in the past year?
• What additional work will be performed during the current grant year that is not possible with the budget currently allotted to this year? Thought must be given to how the work will be accelerated; for example, will more staff be hired, effort increased or more assays run?
• Is the request essential? Are costs reasonable, allowable, necessary and in line with the existing budget? Are there new costs that were previously unforeseen? How will the work be affected if the funds are not carried over?
• Can the carryover funds be expended prior to the end of the current budget period?

NOTE: Carryover requests for scholar and trainee slots will only be considered in rare circumstances; carryover requests for scholar/trainee-related expenses and travel could be considered.

If the request is approved, a revised Notice of Award will reflect the additional authorized funds for the current budget period. If carryover is denied, you will receive correspondence from the GMS.

If all of the above documentation and justifications are provided, the carryover process should take no more than 30 days from receipt to notification of a decision.

Managing Unobligated Balances

Appropriations law requires all federal agencies to abide by the Bona Fide Needs Rule. This rule mandates that a fiscal year’s appropriations only be obligated to meet a legitimate or bona fide need arising in the fiscal year for which the appropriation is made.

In accordance with the Bona Fide Needs Rule and the NIH Grants Policy Statement Section 8.4.1.5.4, NIH is required to manage any reported unobligated balances as part of our fiduciary responsibility for proper stewardship of federal funds.

Unobligated funds are expected to be used before newly awarded funds. Accordingly, the Grants Management Officer (GMO) will compare the total of any unobligated balance shown and the funds awarded for the current budget period with the NIH share of the approved budget for the current budget period. If the funds available exceed the NIH share of the approved budget for the current budget period, the GMO may offset the current award or a subsequent award by an amount representing some or all of the excess.

NCATS is governed by the following guiding principles:

• Balances greater than 100 percent of the Total Costs to be awarded will be used as an offset for current fiscal year grant activities.
• Balances reported on grants in their final year of the project period also may be used as an offset for the current fiscal year grant activities. However, in general, a balance of up to 25 percent of the Total Costs (TC) of the last award is considered reasonable to maintain for unexpected needs, closeout and/or necessary acceleration due to recycling. In cases in which it is known that a new competing segment will be funded, NCATS may leave less than 25 percent of the TC of the last award, as it is anticipated the new award will provide necessary costs for the activity.
• Balances reported on all other grants may be used as necessary for overarching program needs and management. Again, a balance of up to 25 percent of the TC of the last award is considered reasonable to maintain for unexpected needs, closeout, and/or necessary acceleration.

In no case does the offsetting of an award constitute the reduction of the current budget period award in that the total authorized level of federal activity remains the same. However, that activity is “paid for” by a combination of prior fiscal year funds and current fiscal year funds.

Foreign Components

NCATS provides notification to award recipients on the eligibility of foreign institutions in the applicable funding opportunity announcement (FOA) under Section III, Eligibility Information. NCATS award recipients under FOAs that permit foreign participation must request prior approval to add or change a foreign component. Exceptions to obtaining NCATS prior approval cannot and will not be granted.

In accordance with the NIH Grants Policy Statement, a foreign component is defined as performance of any significant element or segment of the project outside the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended.

Activities that would meet this definition include, but are not limited to, the following:

• The involvement of human subjects or vertebrate animals at a foreign site;
• Extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling and similar activities; and/or
• Any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country.

Examples of other grant-related activities that may be considered significant include the following:

• Collaborations with investigators at a foreign site that are anticipated to result in co-authorship;
• Use of facilities or instrumentation at a foreign site; and/or
• Receipt of financial support or resources from a foreign entity.

Examples of grant-related activity that is not considered a foreign component include the following:

• Foreign travel exclusively for consultation and/or conference attendance.
• Conference grant (R13/U13) support of travel exclusively for conference attendance. (Support for international conferences and/or individuals who may contribute significantly to the program may require prior approval.)
• In cases where all grant-related research is being conducted in the United States and involves a researcher or other project team member who has support from a foreign source. (NOTE: This non-U.S.-based resource must be reported as Other Support.)

Prior Approval Requirements

Adding, changing or transferring work to a foreign component under a grant to a domestic or foreign award requires NCATS prior approval. This includes the addition of a performance site or research project in a country other than that specified in the competing application and/or a change in the performance site within a foreign country. The transfer of work by a domestic award recipient to a foreign entity also requires NCATS prior approval.

Submission of a Prior Approval

Award recipients are highly encouraged to contact the assigned PO and GMS to discuss any plans for adding or changing a foreign component before submitting a prior approval request.

All requests must be submitted by the AOR from the grantee institution via email to NCATSPriorApprovalRequest@mail.nih.gov with a copy to the PO and GMS assigned to the grant. Requests should be submitted at least 30 days prior to the proposed change and must include all of the following information:

• Description of the planned activity to be conducted in a foreign country, detailed budget (if any funds will be provided) and timeline of planned activities. (NOTE: Funds for grant awards are paid in U.S dollars; NIH will not adjust/compensate for currency exchange fluctuations after award. Additionally, the maximum facilities and administrative costs for an international consortium is 8 percent of the modified total direct costs, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.)
• Identification of countries with which international cooperative activities are planned.
• Description of special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment and techniques), including the reasons the facilities or other aspects of the proposed project are more appropriate than a domestic setting.
• Description of how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources and intellectual rapport).
• Discussion of ways the proposed studies will benefit from unique features of the scientific environment or from unique subject populations, or how studies will employ useful collaborative arrangements.
• Specific explanation of why this activity cannot be completed in the United States.
• For training requests: the name of the scholar/trainee and a detailed justification for the foreign training, including the reasons the facilities, the mentor, the timeline and/or other aspects of the proposed experience are more appropriate in a foreign setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear. (See: 11.2.2.5 Sponsorship, Foreign Sponsorship in the NIH Grants Policy Statement. 
• If human/animal research, select agents and/or highly pathogenic agents are involved: a description of the plans for ensuring appropriate research protocol review and approval.
• If multiple performance sites are involved: a description of the resources available at each site.

Review Process and Approval Notification

Award recipients must not begin any foreign component activity until official NCATS prior approval is received via a revised Notice of Award or formal approval documentation provided by the NCATS Division of Extramural Activities. Engaging in foreign component activity prior to receiving NCATS prior approval will result in non-compliance enforcement action.

Upon receipt of the prior approval request, NCATS Program and Grants Management Staff will review the request to determine eligibility, allowability and appropriateness of the activity to the approved scope of work. If there is a determination to move forward with the request, NCATS staff will proceed with necessary secondary reviews through the NIH Fogarty International Center and/or U.S. Department of State. (NOTE: Due to the requirements for additional review and oversight for foreign components, award recipients should anticipate significant delays.)