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U.S. Department of Health and Human Services

Prior Approval Requirements

Change in scope

A change in scope always requires prior approval under both non-construction and construction grants. A change in scope occurs when the recipient or ASPR proposes to change (or changes) the objectives, aims, or purposes identified in the approved application. Actions which may be considered a change in scope include, but are not limited to:

  • a shift of the research emphasis from one disease area to another;
  • a change in the service area;
  • application of a new technology (e.g., changing assays from those approved to a different type of assay);
  • a change in the approved design under a construction grant;
  • a change from the approved use of animals or human subjects;
  • transfer of substantive programmatic work to a third party through a subaward or contract, unless included as an expanded authority. If the transfer involves a foreign component under a grant to a domestic or foreign organization, this type of action always requires prior approval (see “Change in recipient, performer, or place of performance” below);
  • significant rebudgeting (see section 903.4.2.1.1);
  • incurrence of research patient care costs if no costs were approved in that budget category or if a recipient wants to rebudget funds out of the research patient care; or
  • purchase of a unit of equipment exceeding $25,000.

Documents required:

  • Program Abstract
  • Position Description and Resumes (if new staff are proposed)
  • Detailed Budget Justification (if changes in budget are significant; refer to Budget Revision)

Change in the Principal Investigator or Project Director or other key personnel

The following actions require prior approval:

  • Replacement of the principal investigator (PI) or project director (PD) or other key personnel specified in the NoA (for both non-construction and construction grants); and
  • Change in status of the PI/PD under a non-construction grant, i.e., if the PI/PD will be absent from the project during any continuous period of three (3) months or more, or reduce time devoted to the project by 25 percent or more from the level that was approved in the NoA.

Documentation required:

  • Rational and justification for the change
  • Impact the change will have on the budget
  • Curriculum Vitae or Resume of new key personnel
  • Position Description

Change in recipient or performer

The following actions require prior approval as indicated:

  • change of recipient (grantee) – contact Grants Management personnel for documentation and requirements needed for this process
  • transfer of substantive programmatic work under a non-construction grant, and
  • involvement of a foreign component, including:
    • involvement of project staff or individuals employed by a foreign organization (under a subaward or contract under the grant) in any activity that may involve the population, environment, resources, or affairs of a foreign country. OPDIVs must obtain concurrence from Department of State before awarding funds to foreign or international organization or to domestic organizations with a foreign component (See Chapter 409);
    • any research within a foreign country involving the use of human subjects (exempt or non-exempt) or vertebrate animals; and
    • foreign travel by recipient project staff to carry out the purpose of the award. 

Documentation Required:

  • Rational and justification for the change
  • Impact the change will have on the budget

Changes from the approved budget

Significant rebudgeting  - if the grantee moves over 25% of the approved budget between costs categories it is considered significant rebudgeting.  The 25% mark is cumulative over the entire budget period.  Grantees have the ability to redirect up to 25% of the total approved budget to achieve stated goals and objectives without prior approval except when:

  • Funds are reallocated to a budget category initially funded at “0” dollars.
  • It requires purchase of equipment exceeding $5,000.
  • There are changes within the contract cost category.
    • There is reallocation of funds and/or changes to indirect costs;
    • Direct costs specified in the applicable cost principles as requiring prior approval unless provided as an expanded authority under non-construction grants. Prior approval cannot be waived for capital expenditures for land or buildings, or indemnification of the recipient for liabilities to third parties or any other loss or damage not compensated by insurance or otherwise;
    • Inclusion of patient care costs in research grants for recipients as specified in 45 CFR 74.25(c)(8) and 92.30(d)(5)) (incurrence of research patient care costs if no costs were approved in that budget category or rebudgeting of funds out of the research patient care category are indicators of a change in scope;
    • Rebudgeting funds for training allowances (direct payments to trainees) to another budget category(ies);
    • Transfers of funds between construction and non-construction activities;
    • Alterations and renovations (A&R) under a non-construction grant if the cost exceeds the specified threshold established by the OPDIV; and
    • Use of funds budgeted for an individual’s salary and fringe benefits, but available as a result of receiving a Career Development Award for that individual.

Documentation needed:

  • Indicate the bona-fide need of the revision, acknowledge that the redirection remains within the scope of the program announcement and will be used to support the ongoing activities of the grant award, provide a detailed description of the changes within the budget and what budget categories will be affected
  • SF 424A: Budget Information Form
  • Budget Narrative Justification.  Provide a breakdown of all costs. Please note that the budget must not exceed the original authorized amount.  All budgets should be in dollar amounts only. Do not include cents
  • Current Indirect Cost Rate Agreement, if requesting a change in indirect costs

Other changes

Other changes that require prior approval include the following:

  • deviation from the terms and conditions of the award
  • additional time to spend previously awarded funds
  • carryover of an unobligated balance of federal funds 

Deviation from terms and conditions

This may include:

  • A request to extend the due date for a report requirement (other than required audits)
  • Change in reporting elements

Request should include justification as to why grantee needs to deviate from the terms and conditions. In the case of requesting a change in report due dates the date on which the reports will be submitted.

Carry-Over Funds

Carry-over of unobligated funds should be requested to support one-time activities that align with the grantee’s existing goals and objectives.  Carry-over requests must supplement the new budget year, not supplant the approved budget for that year.

Funding is subject to match requirements. Match requirements are based on the year in which the carry-over request is awarded.

  • The carry-over request should be submitted only after the annual financial report has been completed and an unobligated balance for the applicable budget year has been determined.
  • Approved carry-over funds must be obligated in the year in which they are awarded, and are intended to cover only prospective costs, not costs already incurred by the recipient.  Use of carry-over funds prior to official approval may result in disallowed costs.
  • Requested funds support one-time activities.  Approval for these activities does not constitute an automatic approval for funding of these activities in the future.

Additional documents required:

In the request you should indicate the reason for unobligated funds from the prior year.  Outline the activities that will be completed using carryover funds, how the activities relate to the existing and approved work plan.  Provide a statement of bona-fide need; include an explanation of how funds will enhance current activities, and timeline/period of performance for proposed activities.

  • Annual financial report, which documents total unobligated funds.
  • SF 424A: Budget Information Form. This should be the total of the original approved budget and the carryover request combined.
  • Budget Narrative Justification.  Provide a breakdown of all costs. This budget should reflect both the original approved budget and the carryover request combined.  All budgets should be in dollar amounts only. Do not include cents. 

Proposed expenses must be within the scope of the original project. The carry-over funds cannot be expended until a revised Notice of Award is signed and approved by the GMO.  Spending funds before this approval is received is at the grantee’s own risk.

No-Cost Time Extension

This request only applies to grantees in their last year of funding or project period.

A no-cost time extension may be requested if the grantee requires additional time beyond the established expiration date (project end-date) to fully complete its program plans and objectives proposed in the original application, unless otherwise indicated in the terms of the award.  The fact that funds remain at the expiration of the grant is not, in itself, sufficient justification for a no-cost extension.  The grantee must submit a request for an extension to the ASPR no later than 30 days prior to the expiration date of the project period.  The letter must explain why you did not accomplish your program goals within the 12 month time frame and what you intend to accomplish in the requested amount of time.

The recipient may extend the final period of a previously approved project period one time for a period of up to 12 months beyond the original expiration date shown in the Notice of Award if:

  • No additional funds are required to be obligated by the awarding office,
  • The originally approved scope will not change,
  • Any one of the following applies:
      • Additional time beyond the established expiration date is required to ensure adequate completion of the originally approved project or program,
        • Continuity of grant support is required while a competing continuation application is under review, and/or
        • The extension is necessary to permit an orderly phase-out of a project or program that will not receive continued support.

      Additional documents required:

      You must address the bona-fide need for the extension and acknowledge that the no cost time extension remains within the scope of the program announcement and will be used to support the closeout of activities funded under the grant award. It must outline how the estimated remaining funds will be used to closeout the project activities.  Include a breakdown of costs category and justification.

      Subrecipient Monitoring

      Once a grant is awarded, the recipient is responsible for establishing and maintaining the necessary processes to monitor its compliance and that of its employees and, as appropriate, subrecipients and contractors under the grant with these requirements; taking appropriate action to meet the stated objectives; and informing ASPR of any problems or concerns.

      The recipient must enter into a formal written agreement with each subrecipient that addresses the arrangements for meeting the programmatic, administrative, financial, and reporting requirements of the grant, including those necessary to ensure compliance with all applicable Federal regulations and policies.  Domestic organizations that receive funding from recipients as subrecipients or contractors under grants rather than directly from HHS also are required to file an HHS 690. The recipient is responsible for determining whether those organizations have the required assurance on file and, if not, ensuring that it is filed with OCR.  Subrecipients and contractors under grants are subject to the requirements of the cost principles otherwise applicable to their type of organization and to any requirements placed on them by the recipient to be able to comply with the terms and conditions of the award.

      These tools from the Association of Government Auditors (AGA) have been reviewed by the HHS Office of the Inspector General as relevant tools for administering and monitoring grant programs.

      • This page last reviewed: November 20, 2017