For the following categories or types of actions (and those in Table II-2), prior approval is required whether or not the change has a budgetary impact.
Change in Scope: In general, the PI may make changes in the methodology, approach, or other aspects of the project objectives. However, the grantee must obtain prior approval from NIH for changes in scope, direction, type of training, or other areas that constitute a significant change from the aims, objectives, or purposes of the approved project (hereafter "change in scope"). The grantee must make the initial determination of the significance of a change and should consult with the GMO as necessary. However, as noted, certain actions in the following list always require NIH prior approval under the circumstances specified.
Actions likely to be considered a change in scope include, but are not limited to, the following:
- Change in the specific aims approved at the time of award.
- Substitution of one animal model for another.
- Any change from the approved use of animals or human subjects.
- Shifting the research emphasis from one disease area to another.
- A clinical hold by FDA under a study involving an IND or an IDE
- Applying a new technology, e.g., changing assays from those approved to a different type of assay.
- Transferring the performance of substantive programmatic work to a third party through a consortium agreement, by contract, or any other means. NOTE: This type of action always requires NIH prior approval for grants not subject to expanded authorities. If the third party is a foreign component, this prior approval requirement also applies to grants subject to expanded authorities (see "Expanded Authorities" in this subsection).
- Change in key personnel (see "Change in Status, Including Absence, of Principal Investigator and Other Key Personnel" for requirements for NIH approval of alternate arrangements for or replacement of key personnel).
- Significant rebudgeting, whether or not the particular expenditure(s) require prior approval. Significant rebudgeting occurs when expenditures in a single direct cost budget category deviate (increase or decrease) from the categorical commitment level established for the budget period by more than 25 percent of the total costs awarded. For example, if the award budget for total costs is $200,000, any rebudgeting that would result in an increase or decrease of more than $50,000 in a budget category is be considered "significant rebudgeting." The base used for determining significant rebudgeting excludes the effects of prior year carryover balances but includes competing and noncompeting supplements.
- Incurrence of patient care costs if not previously approved by NIH or if a grantee desires to rebudget additional funds into or rebudget funds out of the patient care category. NOTE: These types of actions always require NIH prior approval for grants not subject to expanded authorities (see "Expanded Authorities" in this subsection).
Preaward Costs: See "Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Preaward (Preagreement) Costs."
Change in Status, Including Absence, of Principal Investigator and Other Key Personnel: The grantee is required to notify NIH if the PI or other key personnel named in the NGA will withdraw from the project entirely, be absent from the project during any continuous period of 3 months or more, or reduce his or her time devoted to the project by 25 or more percent from the level that was approved at the time of award (for example, a proposed change from 40 percent effort to 30 percent or less effort). NIH must approve any alternate arrangement, including any replacement PI or other key personnel proposed by the grantee.
The request for approval of a substitute PI/key person should include a justification for the change, the biographical sketch of the individual proposed, other sources of support, and any budget changes resulting from the proposed change. If the arrangements proposed by the grantee, including the qualifications of any proposed replacement, are not acceptable to NIH, the grant may be suspended and/or terminated. If the grantee wishes to terminate the project because it cannot make suitable alternate arrangements, it must notify the designated GMO, in writing, of its wish to terminate, and NIH will forward closeout instructions.
Change of Grantee Organization: NIH prior approval is required for the transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the expiration date of the approved project period. Such a change of grantee organization may be accomplished under most NIH grants, including construction grants, if:
- The grant to be transferred has been terminated in accordance with 45 CFR 74.61 or 92.43;
- A noncompeting continuation award that is within an approved project period has been withheld because of the grantee's actions (see "Administrative Requirements—Enforcement Actions—Suspension, Termination, and Withholding of Support"); or
- The original grantee has agreed to relinquish responsibility for an active project before the expiration of the approved project period. This includes any proposed change of grantee as a result of a PI on a research project transferring from one domestic organization to another domestic organization or from a foreign organization to a domestic organization. The project under the same PI may be supported at a new organization for a period up to the remainder of the previously approved project period in an amount not to exceed that previously recommended for direct costs (plus applicable F&A costs) for the remaining period.
A change of grantee that involves the transfer of a grant to or between foreign institutions or international organizations requires competitive review and approval of the IC Advisory Council/Board. Transfer of a grant from a foreign organization to a domestic organization requires the approval of the GMO.
A grant to an individual may not be transferred. However, an individual fellowship may be transferred to a new organization and this would be considered a change of grantee organization. A change in an individual fellow's department or sponsor within the same organization is not considered a change of grantee organization.
A change of grantee organization may involve the transfer of equipment purchased with grant funds. The transfer may be accomplished as part of the original grantee's relinquishment of the grant; otherwise, NIH reserves the right to transfer title to equipment to the new organization as indicated in "Administrative Requirements—Management Systems and Procedures—Property Management System Standards."
A request for a change of grantee organization must be submitted to the designated GMO and must be accompanied by a Relinquishing Statement and a Final Invention Statement and Certification from the original grantee as well as an application (PHS-398) from the proposed grantee. If the original award was the result of a modular application, modular procedures also apply to the request for change of grantee. The application (for awards other than those made under modular procedures) from the proposed grantee should include, at a minimum:
- A face page;
- Budget pages (current and future years);
- An updated biographical sketch;
- A statement indicating whether the overall research plans/aims have changed from the original submission, and, if so, providing updated information;
- An updated "other support" page(s), if necessary;
- A resources page;
- A checklist page;
- Certification of IRB/IACUC approval, if applicable; and
- If the change includes the transfer of equipment purchased with grant funds, the application must include a detailed list. This list, as part of a transfer application, serves as an acceptance of title by the new organization. NIH may request additional information necessary to accomplish its review of the request.
For a modular application, the proposed grantee must submit the following:
- A face page;
- Narrative budget information, including total direct costs and F&A costs for the current budget period;
- Biographical sketches for key personnel;
- "Other support" pages;
- Resource page;
- Checklist page; and
- If future budget periods remain, information regarding the number of modules and the basis for computing F&A costs.
A change of grantee organization request must be made prior to the anticipated start date at the new organization and preferably several months in advance. Failure to provide timely notification may result in disapproval of the request or a delay in processing.
A change of grantee request will normally be permitted only when all of the permanent benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without competitive review, provided the PI plans no significant change in research objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require a competitive review or may disapprove the request and, if appropriate, terminate the award.
As stated above, the original grantee must provide a written statement relinquishing its interests and rights to the grant in accordance with instructions from the NIH awarding office. Acceptance of a Relinquishing Statement by NIH does not guarantee approval of a transfer application for the continued funding of a project.
NIH will accomplish a change of grantee organization by issuing a revised NGA to the original grantee, which will reflect the revised budget/project period end dates, deletion of any future-year support, and deobligation of remaining funds, if applicable. (A deobligation of funds will be based on the estimated grant expenditures through the relinquishment date, as determined from the Relinquishing Statement.) Concurrently, the new grantee will receive an NGA reflecting the balance reported on the Relinquishing Statement or, if the change of grantee organization occurs on the anniversary date of the project, the NGA to the new grantee will reflect the previously committed direct cost level plus applicable F&A costs). This amount is subject to change as a result of the closeout of the original grant and may be adjusted downward.
Change in Grantee Organizational Status: Grantees must notify NIH, in advance, of certain changes in organizational status. This notification is required to ensure that the grantee is still able to meet its legal and administrative obligations to NIH and that payments are not interrupted.
The following organizational changes must be reported to NIH prior to the change:
- Successor-in-Interest: A process whereby the rights to and obligations under an NIH grant(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s). A transfer of this type may result from legislative or other legal actions, such as a merger or other corporate change.
- Name Change: An action whereby the name of an organization is changed without otherwise affecting the rights and obligations of that organization as a grantee.
- Merger: A legal action resulting in the unification of two or more legal entities. When such an action involves the transfer of assets, the procedures for recognition of a successor-in-interest will apply. When the action does not involve the transfer of assets, the procedures for recognition of a name change will normally apply.
Neither a name change nor a successor-in-interest is considered a "change of grantee organization."
Grantees are encouraged to contact the GMO of the lead IC to explain the nature of the change and receive guidance on whether it will be treated as a name change or successor-in-interest. The lead IC will ordinarily be the IC with which the organization has the most NIH grants. If there is no advance consultation, NIH reserves the right to review the material provided, seek clarification or additional information, and make an independent determination.
A grantee's formal request for a successor-in-interest or name change should be submitted to NIH as soon as possible so that NIH can determine whether the organization will continue to meet the grant program's eligibility requirements and take the necessary action to reflect the change in advance of the change in status.
For a successor-in-interest, a letter signed by the appropriate organizational officials of the current grantee (transferor) and the successor-in-interest (transferee) must be sent to the affected NIH ICs, following consultation with the GMO of the lead IC. The letter must:
- Stipulate that the transfer was properly effected in accordance with applicable law,
- Indicate that the transferor relinquishes all rights and interests in all of the affected grants,
- Request that the NIH awarding office(s) modify its records to reflect the transferee as the grantee of record, and
- State the effective date of the transfer.
The letter should be accompanied by: a list of the grants to be transferred; a revised completed grant application face page for the affected grant(s) showing the transferee as the applicant organization, along with information regarding changes in taxpayer identification or entity identification numbers, F&A costs (including a copy of the rate agreement), and the use of human subjects or animals. Upon receipt and acceptance of this information, NIH will revise the NGA(s) to show the transferee as the grantee of record.
For name changes, the grantee's written notification to the lead NIH IC must include the effective date of the change. Revised face pages are not required for name changes since name changes are processed with the next award action and a face page will be received from the organization as part of that action.
Addition of a Foreign Component: Adding a foreign component under a grant to a domestic organization.
Award Terms and Conditions: Deviations from special terms or conditions stated in the NGA or from the terms and conditions included in this policy statement.
Restrictions on Notice of Grant Award: Undertaking any activities disapproved or restricted as a condition of the award.
Carryover of Unobligated Funds from One Budget Period to Another Within an Approved Project Period: NOTE: This action generally is allowable without prior approval under expanded authorities unless restricted (see "Expanded Authorities" in this subsection).
Extension of a Project Period With or Without Additional Funds: A request for a noncompeting extension of a project period should be submitted to the designated GMO, in writing, at least 30 days before the project period is scheduled to expire. Such requests are usually for a period of up to 12 months, based on a need to provide continuity of project activities while a competing continuation application is being reviewed or to permit orderly phaseout of project activities for which there will be no further NIH support, and may request a minimal amount of additional funds. The request must specify the proposed revised ending date and must include justification for both the extension and any additional funds requested. Special justification will be required for an additional extension that would exceed an initial 12-month extension. NIH will not approve such requests if the primary purpose of the proposed extension is to permit the use of unobligated balances of funds. NOTE: These requirements generally do not apply under expanded authorities with respect to a "no-cost" extension of the final budget period of a project period (see "Expanded Authorities" in this subsection).
Equipment Purchase: Equipment exceeding $25,000 per unit, regardless of the amount of NIH funding to be used. NOTE: This requirement generally is not applicable under expanded authorities unless the purchase may be considered result ina change in scope (see "Expanded Authorities" in this subsection).
Retention of Research Grant Funds When a Career (K) Award is Made: Funds budgeted under an NIH grant for an individual's salary and/or fringe benefits, but available as a result of receiving a career (K) award for that individual, may not be used for any other purpose without NIH prior approval.
Alterations and Renovations: NIH prior approval is required for an A&R project exceeding $300,000 (see "Construction Grants—Administrative Requirements—Prior Approval Requirements—Alteration and Renovation Projects under Non-construction Grants" for documentation requirements).
Transferring Amounts from Trainee Costs: The transfer of amounts previously awarded for trainee costs (stipends, tuition, and fees) to other categories of expense. This excludes trainee travel, which NIH does not consider to be a trainee cost, and training-related expenses (see "National Research Service Awards—Institutional National Research Service Awards (Training Grants)—Financial Provisions—Rebudgeting of Funds").
Capital Expenditures: Capital expenditures for land or buildings. In addition, real property acquired with NIH grant funds may not be conveyed, transferred, assigned, mortgaged, leased, or in any other manner encumbered by the grantee without the written prior approval of the NIH awarding office or its successor organization.
Need for Additional NIH Funds: A request for additional funding for a current budget period to meet increased costs that are within the scope of the approved application, but that were unforeseen when the new, noncompeting continuation, or competing continuation application was submitted, is a noncompeting supplemental application. Such requests are submitted directly to the GMO, in writing, and are not required to compete with other applications for funding.
Closely Related Work: When salaries or other costs are being supported by two or more scientifically and technically related NIH grant projects, grantees may charge those costs to any one of those projects or treat multiple projects as a single cost objective only with NIH prior approval. NIH will not approve such requests if there is a change in the scope of the individual grants involved, relating the costs will be detrimental to the conduct of work approved under each individual award, or the projects are being related to circumvent the terms and conditions of an individual award. (See "Cost Considerations—Allocation of Costs and Closely Related Work.")
Transfer of Funds Between Construction and Non-construction: Under awards that provide for both construction and non-construction work, NIH prior approval is required to transfer funds between the two types of work.
Program Income: The use of any alternative for disposition of program income other than that specified in the terms and conditions of award must have NIH prior approval (see "Administrative Requirements—Management Systems and Procedures—Program Income").
NIH has waived the requirement for its prior approval of those expenditures and activities specified in this subsection and has provided the authorities (hereafter "expanded authorities") to grantees to take such actions without NIH prior approval. In using these expanded authorities, grantees must ensure that they exercise proper stewardship over Federal funds and that costs charged to the awards are allowable, allocable, reasonable, and consistently applied regardless of the source of funds. Expanded authorities apply to the following mechanisms:
- "R" series (Research Project Grants), except R41, Phase I Small Business Technology Transfer (STTR) Grants, and R43, Phase I Small Business Innovation Research (SBIR) Grants.
- Program Project Grants (P01).
- "K" series (Career Awards).
NIH ICs also may authorize some or all of the expanded authorities for additional awards or classes of awards.
Expanded authorities are not provided under awards to individuals. Certain support mechanisms or grantees also may be excluded from expanded authorities. This may include grants or grantees that require closer project monitoring or technical assistance, such as clinical trials and certain large multi-project grants. If excluded, the NGA will indicate this change from the standard terms and conditions. In addition, one or more of these authorities may be overridden by a special term or condition of the award. Therefore, grantees must review the NGA to determine whether and to what extent they are permitted to use expanded authorities. Several of the expanded authorities have specific deadlines for submission of reports or for timely notification to the NIH awarding office. Grantees should be aware that any consistent pattern of failure to adhere to those deadlines for reporting or notification shall be grounds for excluding that grantee from these special authorities. Even where the grantee is authorized to use expanded authorities, if it is determined, through audit or otherwise, that costs do not meet the tests of allowability, allocability, reasonableness, and consistency, the costs may be disallowed.
Extension of a Project Period Without Additional Funds: The grantee may extend the final budget period of the project period one time for a period of up to 12 months beyond the original expiration date shown in the NGA if no additional funds are required to be obligated by the NIH awarding office, there will be no change in the project's originally approved scope, and any one of the following applies:
- Additional time beyond the established expiration date is required to ensure adequate completion of the originally approved project.
- Continuity of NIH grant support is required while a competing continuation application is under review.
- The extension is necessary to permit an orderly phaseout of a project that will not receive continued support.
The fact that funds remain at the expiration of the grant is not, in itself, sufficient justification for an extension without additional funds.
The grantee must notify the NIH awarding office, in writing, of the extension 10 days prior to the expiration date of the project period. Upon notification, the NIH awarding office will revise the project period ending date and provide an acknowledgment to the grantee. In extending the final budget period of the project period through this process, the grantee agrees to update all required certifications, including human subjects and animal welfare, in accordance with applicable regulations and policies. Grantees may not extend project periods previously extended by the NIH awarding office. Any additional project period extension beyond the one-time extension of up to 12 months requires NIH prior approval. (See "Prior Approval Requirements" in this section for extensions requiring additional funds.)
Carryover of Unobligated Balances: Except for funds restricted in an NGA, unobligated funds remaining at the end of a budget period are automatically carried over. For awards under the Streamlined Noncompeting Award Process (SNAP), funds are automatically carried over and are available for expenditure during the entire project period. However, under those awards, the grantee will be required to indicate, as part of its noncompeting continuation request, whether its estimated unobligated balance (including prior year carryover) is expected to be greater than 25 percent of the current year's total budget. If so, the grantee must provide an explanation and indicate plans for expenditure of those funds if carried forward. (See "Administrative Requirements—Noncompeting Continuation Awards.")
For those awards subject to expanded authorities but excluded from SNAP, e.g., P01s and R35s, the FSR must specify the amount to be carried over. The notification must be provided under item 12, "Remarks," on the FSR. When a grantee reports a balance of unobligated funds in excess of 25 percent of the total amount awarded, the GMO will review the circumstances resulting in the balance to ensure that these funds are necessary to complete the project, and may request additional information from the grantee, including a revised budget, as part of the review. If the GMO determines that some or all of the unobligated funds are not necessary to complete the project, the GMO may take one, or a combination, of the following actions: restrict the grantee's authority to automatically carry over unobligated balances in the future, or use the balance to reduce or offset NIH funding for a subsequent budget period. Any amount not identified for carryover may be used as an offset. A revised NGA will not be issued to reflect the carryover.
Use of Program Income: The additive costs alternative for the use of program income applies to awards subject to expanded authorities unless the NGA specifies another alternative or the grantee is a for-profit organization other than an SBIR/STTR awardee. For-profit organizations other than SBIR/STTR awardees are subject to the deductive alternative (see "Administrative Requirements—Management Systems and Procedures—Program Income").
Transferring the Performance of Substantive Programmatic Work to a Third Party by Means of a Consortium Agreement, Contract, or Other Means: Under expanded authorities, a grantee is not required to obtain NIH prior approval for transferring the performance of substantive programmatic work unless the activity constitutes a change in scope or results in the transfer of substantive programmatic work to a foreign component.
Cost-Related Prior Approvals, Including Patient Care and Equipment: Requirements for NIH approval of incurrence of these individual costs, including rebudgeting for them, do not apply under expanded authorities unless they constitute a change in scope.
Requests for Approval
All requests for NIH awarding office prior approval must be made, in writing (which includes submission by e-mail) to the designated GMO no later than 30 days before the proposed change. The request must be signed by both the PI and the authorized organizational official. Failure to obtain prior approval, when required, from the appropriate NIH awarding office may result in the disallowance of costs, termination of the award, or other enforcement action within NIH's authority.
E-mail requests must be clearly identified as prior approval requests and reflect the complete grant number in the subject line, and they should be sent to the GMO that signed the NGA. E-mail addresses for NIH staff can be obtained from the NIH Directory and E-Mail Forwarding Services at http://directory.nih.gov. E-mail requests must include the name of the initiating PI, grantee name, the PI's telephone number, fax number, and e-mail address, and must be transmitted to NIH by the authorized organizational official, who must include comparable identifying information. If the entire message of the request cannot be included in the body of the e-mail, the request should be submitted to NIH in hard copy.
The GMO will review the request and provide a response to the authorized organizational official indicating the final disposition of the request. The GMO will provide copies of the response to the PI and to the cognizant NIH Program Official. Only responses provided by the GMO are to be considered valid. Grantees that proceed on the basis of actions by unauthorized officials do so at their own risk, and NIH is not bound by such responses.
Whenever grantees contemplate rebudgeting or other postaward changes and are uncertain about the need for prior approval, they are strongly encouraged to consult, in advance, with the GMO.
Under a consortium agreement, the prior approval authority is usually the grantee. However, the grantee may not approve any action or cost that is inconsistent with the purpose or terms of the NIH grant. If an action by a consortium participant will result in a change in the overall grant project or budget requiring NIH approval, the grantee shall obtain that approval from NIH before giving its approval to the consortium participant.
Noncompeting Continuation Awards
The "Application for Continuation of a Grant" (PHS-2590) or equivalent documentation must be submitted to, and be approved by, NIH to noncompetitively fund each additional budget period within a previously approved project period. Except for awards subject to SNAP, the application includes an updated budget, progress report, and other required information.
Noncompeting continuation applications must be submitted directly to the IC GMO 2 months before the beginning date of the next budget period, unless instructed otherwise. Late submission or receipt of an incomplete noncompeting continuation application will result in delaying the issuance and funding of the noncompeting continuation award and may result in a reduced award amount.
Streamlined Noncompeting Award Process
NIH grantees (including those participating in the FDP) are expected to follow the streamlined noncompeting process (SNAP) for mechanisms routinely covered under expanded authorities except Program Project Grants (P01s) and Outstanding Investigator Grants (R35s) (see "Administrative Requirements—Changes in Project and Budget—Expanded Authorities").
Any additional activity that has been included under expanded authorities at the discretion of an IC (e.g., centers, training grants, or cooperative agreements) will be excluded under SNAP unless inclusion is specifically footnoted as a term or condition of the award.
Any award excluded from expanded authorities is routinely excluded from SNAP unless specifically included in SNAP as a term or condition of the award. Individual awards may be excluded from routine inclusion under SNAP (and expanded authorities) on the basis of the following criteria:
- Grants that require close project monitoring or technical assistance, e.g., clinical trials, high-risk grantees, certain large individual or multi-project grants, or grants with significant unobligated balances.
- Grantees that have a consistent pattern of failure to adhere to appropriate reporting or notification deadlines.
Under SNAP, the GMO negotiates the direct costs for the entire competitive segment at the time of the competing award or, in the case of modular awards, determines the applicable number of modules for each budget period within the competitive segment. This eliminates the need for annual budget submissions and negotiations, if applicable, and reduces the information NIH requires to review and approve noncompeting continuation applications and to monitor these awards. As a result, for awards under SNAP, grantees are required to submit only limited portions of the PHS-2590, including an annual progress report. If there is a change in performance site and/or anticipated program income, grantees also must submit the PHS-2590 checklist and, if program income is anticipated, the application should reflect the estimated amount and source of the income. Grantees (other than foreign grantees and Federal institutions) also are required to submit a quarterly Federal Cash Transactions Report (FCTR) (SF-272) to PMS.
As part of the progress report, grantees must answer the following questions:
- Has there been a change in the "other support" of key personnel since the last reporting period? If so, the change(s), including termination of a previously active grant or activation of a previously pending grant, must be explained. If not, the grantee must so state.
- Will there be, in the next budget period, a significant change in the level of effort for key personnel from what was approved for this project? A "significant change" is a 25 percent or greater reduction in time devoted to the project. If so, the grantee must explain; if not, the grantee must so state.
- Does the grantee anticipate that it will have an estimated unobligated balance (including prior year carryover) that will be greater than 25 percent of the current year's total budget? If so, the grantee will be required to explain why there is a significant balance and how it will be spent if carried forward into the next budget period. If not, the grantee should so state.
The IC will rely on the grantee's assessment of whether significant changes have occurred or will occur in these areas; however, the GMO may require additional information in order to evaluate the project for continued funding. Failure to provide this information will result in a delayed award.
For awards under SNAP (other than awards to foreign organizations or Federal institutions), a Financial Status Report (FSR) is required only at the end of a competitive segment rather than annually. This FSR must be submitted within 90 days after the end of the competitive segment and must report on the cumulative support awarded for the entire segment. An FSR must be submitted at this time whether or not a competing continuation award is made. If no further award is made, this report will serve as the final FSR (see "Administrative Requirements—Closeout"). Foreign organizations and Federal institutions must submit an annual FSR even if an award is under SNAP. (Also see "Administrative Requirements—Monitoring—Reporting—Financial Reports.")