Submission of Prior Approval Requests

NCATS recipients are required to adhere to the NIH Grants Policy Statement, unless the Notice of Award (NoA) states otherwise.

Prior approval requests must be submitted via the eRA Commons Prior Approval Module. All prior approval requests must be submitted no later than 30 days before the proposed change and signed by the Authorized Organization Representative (AOR).

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

• Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) (PA-26-001)
• Change of Recipient Organization (Type 7 Parent Clinical Trial Optional) (PA-24-254)
• Successor-in-Interest (Type 6 Parent Clinical Trial Optional) (PA-24-253)

See specific information about this guidance: 

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

As of January 2026, the Prior Approval Module in eRA Commons has been updated to allow the Common Forms required for certain Prior Approval requests to be attached at an individual person-level rather than a single combined PDF document as required by NOT-OD-26-018. NIH has extended the current implementation leniency period allowing for the use of the NIH Biosketch and NIH Other Support format pages through May 2026 (NOT-OD-26-033), recipients are encouraged to use the Common Forms as soon as feasible.

Change in Key Personnel

Prior approval is only required for a significant change in the status of the Program Director (PD)/Principal Investigator (PI) or other Senior/Key Personnel specifically named in the NoA including but not limited to withdrawing from the project entirely, being absent from the project during any continuous period of 3 months or more, or reducing time devoted to the project by 25% or more from the level that was approved at the time of initial competing year award.

Process for Submitting a Change in Key Personnel

All requests must be made via the eRA Commons Prior Approval Module. Requests must be submitted 30 days prior to the proposed change and must include the following information:

• Statement indicating the previously 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 the NIH Grants Policy Statement Section 8 for details)
• Start date for the change
• Budget changes resulting from the proposed change, if any
• Updated Other Support Common Form, 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 Common Form and NIH Biographical Sketch Supplement, a  Current and Pending (Other) Support (CPOS) Common Form, 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.
• If the request is to change from a single PD/PI model to a multiple PD/PI model, or to change the number or makeup of the PD/PIs on a multiple PD/PI award, a new or revised Leadership Plan is required.

Once all 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 through the eRA Commons Prior Approval Module. Requests should be submitted 30 days prior to the proposed change and must include the following information:

• Statement indicating the previously 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 the NIH Grants Policy Statement Section 8 for details)
• Start date for the change
• Budget changes resulting from the proposed change, if any
• Updated Other Support Common Form, 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 Common Form and NIH Biographical Sketch Supplement, a  Current and Pending (Other) Support (CPOS) Common Form, 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, may be required.
• A revised multi-PD/PI Leadership Plan, including a conflict resolution plan

Once all 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. No new activity may occur during an extension period. NCATS currently considers First No-Cost Extensions, Subsequent No-Cost Extensions and Cost Extensions.

First No-Cost Extension

As soon as 90 days prior to the project period end date, recipients 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 NoA via eRA Commons, if—

• No term of award specifically prohibits the extension;
• No additional funds are required to be obligated; and
• There is no change to the originally approved scope of work.

If a recipient misses the deadline to submit a first no-cost extension in the eRA 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 no-cost extension request must be made via the eRA Commons Prior Approval Module. The prior approval request must be submitted no later than 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 NoA must devote a measurable level of effort. Many NCATS grant programs include effort level requirements in the relevant Notice of Funding Opportunity.
• Scientific rationale for continuing the project
• Scope of work to be completed during the extension
• Timeline for completion
• A certification that all certifications and assurances, including Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) approvals have been updated to cover the extension period
• Detailed explanation of why the project could not be completed within the originally approved end date
• 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 does not consider third no-cost extensions except in extremely rare circumstances.

Cost Extension

A cost extension (CE) is a one-time request for an extension of the original final budget period within a project with a minimal amount of funds, for a period of up to 12 months. The purpose of a CE 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 Program Official (PO) 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. CEs are not available to projects already in an extension period. Requests may be submitted electronically in response to the NIH Parent Announcement for Administrative Supplements to Existing NIH Grants and Cooperative Agreements (PA-26-001). CEs submitted after the originally approved project period end date are not eligible for funding consideration. Recipients are strongly encouraged to contact the assigned PO and Grants Management Specialist (GMS) for submission instructions before submitting a CE request.

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.

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

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 rebudgeted to cover requested costs
• Scientific rationale for continuing the project, 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 all personnel, 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 (F&A) rate for parent and subaward sites
• Updated Other Support Common Forms for Key Personnel, if applicable
• Updated certification that all certifications and assurances, including IRB and IACUC approvals have been updated to cover the extension period. (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 the expectation of securing federal grant funds.

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 CEs and does so ONLY in rare circumstances with extraordinary scientific justification.

Unobligated Funds/Carryover

Unobligated funds are 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 and previously approved grant activities in that budget period. An offset is the use of the unobligated funds to partially or fully fund a future budget period for previously approved activities.

Prior Approval Requirements

Most NIH grants have automatic carryover authority, meaning recipients do not have to request approval from NIH to carry over funds from one budget period to the next. Recipients 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 recipient is encouraged to discuss it with their PO and GMS. In addition, the recipient must ensure that the FFRs for the last (and all prior) budget period(s) have been submitted.

Process for Submitting a Carryover Request

Carryover requests must:

• Be limited to actual needs for previously approved grant activities to be conducted during the current budget period,
• Be expended before the end of the current budget period,
• Meet an immediate need, and
• Not result in reoccurring costs.

All carryover requests must be submitted via the eRA Commons Prior Approval Module. 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 rebudgeted to cover the expenses.
• Identification of the requested F&A costs, including F&A rate, for the prime recipient and any subcontracts. (Note: Carryover funds are approved at the originally approved F&A rate at which the funds were awarded.)
• Justification for the request (See below.)

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

• Why were the funds not spent in the past year?
• What previously approved grant activities will be performed during the current grant year that are not possible to perform with the budget currently allotted to this year? How will the work be accelerated (e.g., hiring more staff, increasing the level of effort, running more assays)?
• 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 may be considered if the individual maintains an active appointment.

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

If all 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 the excess.

NCATS is governed by the following guiding principles:

• Balances greater than 100% of the Total Costs (TC) to be awarded will be used as an offset for previously approved grant activities occurring in the current fiscal year.
• Balances reported on grants in their final year of the project period also may be used as an offset for previously approved grant activities occurring in the current fiscal year. However, in general, a balance of up to 25% of the 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% 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% of the TC of the last award is considered reasonable to maintain for unexpected needs, closeout, and/or necessary acceleration.

The offsetting of an award does not constitute the reduction of the current budget 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

Per updated guidance provided by NOT-OD-25-104, NOT-OD-25-155, and NOT-OD-25-130, NCATS will no longer accept prior approval requests to add a new foreign component or subaward to an ongoing project.