Submission of Prior Approval Requests

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

Detailed guidance on the submission requirements for the most common NIH prior approval requests is provided below.

All prior approval requests must be submitted in writing (including submission by email) 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.

NCATS recommends that grantees follow NIH guidance for the electronic submission of requests for administrative supplements and change of grantee organization:

Change in Key Personnel

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

Extensions

An extension is a request for additional time to complete originally approved scope of work beyond the end date of the approved project period. An extension period should not be utilized to expand and/or increase the originally approved scope of work.

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.

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 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
  • 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 originally approved scope of work beyond the end date of the approved project period. An extension period should not be utilized to expand and/or increase the originally approved scope of work.

First No-Cost Extension

Within ninety 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/or
  • the project's originally approved scope will not change.

If a grantee submits a first no-cost extension request after the budget/project period end date (even by one day), the request will not be able to be completed through eRA Commons. A prior approval request with substantial justification for the late submission must be submitted in writing by the AOR to the GMS and PO.

Subsequent No-Cost Extension

Grantees may not automatically extend project periods that were previously extended either by the grantee or by NCATS. Any additional project period extension requires NIH prior approval.

A second or third extension must be submitted via email by an AOR 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.)
  • Scientific rationale for continuing the project
  • Scope of work to be completed during the extension
  • Updated certifications and assurances, including IRB and IACUC approvals
  • Detailed explanation of why you could not finish your project within the originally approved end date
  • Explanation of how will finish your project in this final extension or how you 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 only with extraordinary scientific justification and approval from the PD and Director, Office of Grants Management. If approved, this would be the FINAL extension for the grant.

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 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.