prior approval requirements, A&R, capital expenditures, additional no-cost extension or extension greater than 12 months or late notification of initial no-cost extensions, alterations and renovations, capital expenditures, carryover of unobligated balances, change in scope, change in status, including absence of PD/PI and other senior/key personnel named in the NoA, change of recipient organization, change in recipient organizational status, deviation from award terms and conditions (including restrictions in the NoA), foreign component added to a grant to a domestic or foreign organization, provide subawards based on fixed amounts, need for additional NIH funding without extension of budget and project period, need for additional NIH funding with extension of the final budget period of project period, pre-award costs, rebudgeting of funds from trainee costs, rebudgeting of funds between construction and non-construction work, and retention of research grant funds when a career development award is issued

8.1.2 Prior Approval Requirements

This section describes the activities and/or expenditures that require NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements).. NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). requirements are summarized in Exhibit 7, which is provided for guidance only. For the prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). requirements specified in the exhibit, approval is required whether or not the change has a budgetary impact. The circumstances under which prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). is required also are summarized in the exhibit.

Recipients also should consult Subpart IIB for prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). requirements that apply to specific mechanisms, types of grants, and types of recipients.

Any question about the need for prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). for an activity or cost under a specific NIH award should be directed to the GMO.

Exhibit 7. Summary of Actions Requiring NIH Prior Approval

NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). is required for	Under the following circumstances
Additional no-cost extension, extension greater than 12 months, or late notification of initial no-cost extension (8.1.2.1)	All instances.
A&R (8.1.2.2)	Rebudgeting into A&R costs that would exceed 25 percent of the total approved budget for a budget period. If rebudgeting would not meet this threshold but would result in a change in scope. Addition of a Major single A&R project.
Capital expenditures (construction, land, or building acquisition) (8.1.2.3)	All instances. Also, any proposals to convey, transfer, assign, mortgage, lease, or in any other manner encumber real property acquired with NIH grant funds.
Carryover of unobligated balances (8.1.2.4)	If the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. indicates that the recipient does not have the authority to automatically carry over unobligated balances.
Change in scope (8.1.2.5)	All instances.
Change in status of the PD/PI or senior/key personnel named in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. (8.1.2.6)	A significant change in the status including but not limited to withdrawal from the project; absence for any continuous period of 3 months or more; reduction of the level of effort devoted to project by 25 percent or more from what was approved in the initial competing year award.
Change of recipient organization (8.1.2.7)	All instances.
Change of recipient organization status (8.1.2.8)	All instances.
Deviation from award terms and conditions (8.1.2.9)	All instances. Includes undertaking any activities disapproved or restricted as a condition of the award.
Foreign component added to a grant to a domestic or foreign organization (8.1.2.10)	All instances.
Make subawards based on fixed amounts (8.1.2.11)	All instances
Need for additional NIH funding (8.1.2.12 and 8.1.2.13)	All instances, including extension of a final budget period of a project period with additional funds.
Pre-award costs (8.1.2.14)	More than 90 days before effective date of the initial budget period of a new or competing continuation award; always at the recipient's own risk.
Rebudgeting funds from trainee costs (8.1.2.15)	All instances.
Rebudgeting of funds between construction and non-construction work (8.1.2.16)	All instances.
Retention of research grant funds when CDA awarded (8.1.2.17)	All instances.

8.1.2.1 Additional No-cost Extension or Extension Greater Than 12 Months or Late Notification of Initial No-Cost Extension

The NIH Standard Terms of Award provide the recipient the authority to extend the final budget period of a previously approved project period one time for a period of up to 12 months beyond the original completion date down in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system.. Any additional project period extension beyond the initial extension of up to 12 months requires NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements).. The request should include a description of the project activities that require support during the extension and a statement about the funds available to support the extension. Further any late notification of the initial no-cost extension provided by the NIH Standard Terms of Award also requires prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements)..

All Federal agencies are required by 31 U.S.C. §1552(a) to close fixed year appropriation accounts and cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability, unless otherwise authorized by Congress. In order for NIH to meet its obligation to close these accounts and cancel any remaining balances by September 30, recipients must report disbursements on the FFR no later than August 31^st of the fifth fiscal year after the year of availability. At the end of five years, the funds are cancelled and returned to the Treasury. This provision may limit NIH's ability to further extend the final budget period.

Potential indicators of 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.
Change from the approved use of live vertebrate animals.
Change from the approved involvement of human subjects that would result in an increased risk. This includes:
- An addition or change that would result in changing the overall human subjects or clinical trial designation of the award;
  - From non-human subjects research to research involving human subjects (exempt or non-exempt);
  - From exempt to non-exempt research involving human subjects; or
  - From "No Clinical Trial" to "Includes a Clinical Trial." Requests for this change must be submitted to a clinical trial NOFO as a competitive revision. See NIH definition of clinical trial and 2.3.5 - Types of Notices of Funding Opportunity.
- The new inclusion of subject populations that are covered by additional regulatory protections under 45 CFR Part 46 subparts B, C or D (pregnant women, human fetuses, and neonates; prisoners; or children).
- Any change to the study protocol that would increase the risk level for subjects including physical, psychological, financial, legal or other risks. This could include the addition of a new study population that would be at higher risk from existing research procedures, the addition of new study procedures that are greater than minimal risk, any modification of existing study procedures that would increase overall risk, or the addition of a new clinical study or a new clinical trial intervention arm not originally proposed that is greater than minimal risk.
- New information indicating a higher level of risk to participants than previously recognized for a study intervention, procedure, or pharmacological treatment.
Shift of the research emphasis from one disease area to another.
A clinical hold by FDA under a study involving an IND or an IDE.
Application of a new technology, e.g., changing assays from those approved to a different type of assay.
Transfer of the performance of substantive programmatic work to a third party through a consortium agreement A formalized agreement whereby a research project is carried out by the recipient and one or more other organizations that are separate legal entities. Under the agreement, the recipient must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. These agreements typically involve a specific level of effort from the consortium organization's PD/PI and a categorical breakdown of costs, such as personnel, supplies, and other allowable expenses, including F&A costs. The relationship between the recipient and the collaborating organizations is considered a subaward relationship. (See Consortium Agreements chapter in IIB)., by contract, or any other means. If the third party is a foreign component, NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). is always required.
Change in other senior/key personnel not specifically named in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. (see Change in Status, Including Absence, of PD/PI and Other Senior/Key Personnel Named in the NoA below for requirements for NIH approval of alternate arrangements for or replacement of named senior/key personnel).
Significant rebudgeting, whether or not the particular expenditure(s) require prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements).. Significant rebudgeting occurs when expenditures in a single direct cost Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. budget category deviate (increase or decrease) from the categorical commitment level established for the budget period by 25 percent or more 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 considered significant rebudgeting. The base used for determining significant rebudgeting excludes the effects of prior-year carryover balances but includes competing and non-competing supplements. Significant rebudgeting does not apply to modular grants.
Incurrence of research patient care costs if costs in that category were not previously approved by NIH or if a recipient desires to rebudget additional funds beyond those approved into or rebudget funds out of the research patient care category.
Purchase of a unit of equipment exceeding $25,000.

8.1.2.6 Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA

The recipient is required to submit a prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). request to the GMO if:

There is a significant change in the status of the PD/PI or other Senior/Key Personnel The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as Senior/Key Personnel. specifically named in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. 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 percent or more from the level that was approved at the time of initial competing year award (for example, a proposed change from 40 percent effort to 30 percent or less effort or in calendar months a change from 4.8 to 3.6 calendar months). Reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive reductions that total 25% or more. Once agency approval has been given for a significant change in the level of effort, then all subsequent reductions are measured against the approved adjusted level. Selecting Yes in the RPPR constitutes a prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). request to the agency and the issuance of a subsequent year of funding constitutes agency approval of the request.
There is a change from a multiple PD/PI model to a single PD/PI model.
There is a change from a single PD/PI model to a multiple PD/PI model.
There is a change in the number or makeup of the PD/PIs on a multiple PD/PI award.

NIH must approve any alternate arrangement proposed by the recipient, including any replacement of the PD/PI or senior/key personnel named in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system., and the addition of any new PD/PIs.

The request for prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). of any additional or substitute PD/PIs or Senior/Key Personnel The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as Senior/Key Personnel. named in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system., or change from a multiple PD/PI model to a single PD/PI model, must be submitted promptly, and must be accompanied by a strong scientific justification related to the scientific project, including any proposed changes in scope, the biographical sketch of any new individuals proposed and other sources of support, and any budget changes resulting from the proposed change. A new or revised Leadership Plan is 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. The Commons ID must be provided for any new PD/PIs.

In addition, because NIH recipients are expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research, the request for approval should include mention as to whether change(s) in PD/PI or Senior/Key Personnel The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as Senior/Key Personnel. is related to concerns about safety and/or work environments (bullying, retaliation, or hostile working conditions). NIH recipient institutions are required to notify NIH when individuals identified as PD/PI or other Senior/Key personnel in an NIH notice of award are removed from their position or are otherwise disciplined by the recipient institution due to concerns about harassment, bullying, retaliation or hostile working conditions. Notification must be provided by the Authorized Organization Representative The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This individual is equivalent to the signing official in the eRA Commons, i.e., holds the SO Role. within 30 days of the removal or disciplinary action and must be submitted to NIH through the dedicated web form, Inform NIH About Harassment or Discrimination Concerns.. All required notifications must include, at a minimum, the name of the Authorized Organization Representative The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This individual is equivalent to the signing official in the eRA Commons, i.e., holds the SO Role. submitting the notification, the name of the individual of concern, a description of the concerns, the action(s) taken, and any anticipated impact on the NIH-funded award(s). If it is determined that the concerns shared with NIH will impact the PD/PI or senior key personnel's ability to continue as the scientific lead of the project, NIH will require prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). for a replacement PD/PI or senior key official.

NIH will, in turn, be better positioned to enable informed grant-stewardship decisions regarding matters including, but not limited to, substitute personnel and institutional management and oversight.

If the arrangements proposed by the recipient, including the qualifications of any proposed replacement, are not acceptable to the NIH awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award., the grant may be suspended or terminated. If the recipient wishes to terminate the project because it cannot make suitable alternate arrangements, it must notify the GMO, in writing, of its wish to terminate, and NIH will forward closeout instructions.

The requirement to obtain NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). for a change in status pertains only to those personnel NIH designates in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. regardless of whether the applicant organization designates others as senior/key personnel for its own purposes.

8.1.2.7 Change of Recipient Organization

The original recipient has agreed to relinquish responsibility for an active project before the completion date of the approved project period. This includes any proposed change of recipient as a result of a PD/PI on a research project transferring from one organization to another organization. The project under the same PD/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 Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (plus applicable F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.) for the remaining period.
A non-competing continuation award that is within an approved project period has been withheld because of the recipient's actions (see Administrative Requirements-Enforcement Actions-Suspension, Termination, and Withholding of Support).

A request for change of recipient organization should include mention as to whether the change in recipient institution is related to concerns about safety and/or work environments (e.g. due to concerns about harassment, bullying, retaliation, or hostile working conditions) involving the PD/PI. NIH recipient institutions are required to notify NIH when individuals identified as PD/PI or other Senior/Key personnel in an NIH notice of award are removed from their position or are otherwise disciplined by the recipient institution due to concerns about harassment, bullying, retaliation or hostile working conditions. Notification must be provided by the Authorized Organization Representative The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This individual is equivalent to the signing official in the eRA Commons, i.e., holds the SO Role. within 30 days of the removal or disciplinary action and must be submitted to NIH through a dedicated web form. All required notifications must include, at a minimum, the name of the Authorized Organization Representative The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This individual is equivalent to the signing official in the eRA Commons, i.e., holds the SO Role. submitting the notification, the name of the individual of concern, a description of the concerns, the action(s) taken, and any anticipated impact on the NIH-funded award(s). If it is determined that the concerns shared with NIH will impact the PD/PI or senior key personnel's ability to continue as the scientific lead of the project, NIH will require prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). for a replacement PD/PI or senior key official.

NIH expects both the relinquishing and applicant organizations to disclose whether a Change of Recipient Organization is occurring within the context of an ongoing or recent investigation of misconduct of any kind, including but not limited to professional misconduct or research misconduct Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion..

A change of recipient that involves the transfer of a grant to or between foreign organizations or international organizations also must be approved by the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.'s Advisory Council or Board.

A grant to an individual may not be transferred.

A successor-in-interest or a name change is not considered a change of recipient (see Change in Recipient Organizational Status below).

A change of recipient organization may involve the transfer of equipment purchased with grant funds. The transfer may be accomplished as part of the original recipient'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 change of recipient request normally will 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. NIH will also consider the length of time, the percentage of funds, and the amount of work remaining in the project period. A change may be made without peer review, provided the PD/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 IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. may require peer review or may disapprove the request and, if appropriate, terminate the award.

A change of recipient organization request must be made before 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 significant delays in processing. Recipients are encouraged to discuss any potential issues with the awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.(s) prior to submitting a change of recipient organization request. If requesting a transfer in the middle of a budget period or at the end of the Federal fiscal year, recipients should contact the awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. for IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.-specific guidance on the timing and preparation of the change of institution application.

A request for a change of recipient organization must be submitted to the GMO. The original institution must include an Official Statement Relinquishing Interests and Rights in a Public Health Service Research Grant (PHS 3734) (relinquishing statement). The relinquishing statement may be submitted in paper or electronically via the eRA Commons. Final FFR Expenditure Data and a Final Invention Statement are due to NIH from the relinquishing organization no later than 120 days after the end of NIH support of the project. Final FFR Expenditure Data should not be submitted until the original institution has received a revised NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. for the relinquished grant.

The proposed new recipient institution must provide the GMO with a change of institution application which may be submitted using the PHS 398 or PHS 416-1 paper application forms, or electronically via Grants.gov using the Parent Announcement. If the original award was the result of a modular application and the recipient will submit a paper change of institution application, the modular procedures apply to the request for change of recipient. If the original award was the result of a modular application and the recipient will submit an electronic change of institution application, the recipient may submit a detailed budget or streamlined-detailed budget (as described in the NOFO).

The paper application from the proposed new recipient institution should include, at a minimum, the following:

PHS 398 Face page
Budget pages (current and future years). (Under awards resulting from modular applications, the application should include narrative budget information for the current budget period, including total direct cost Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. and the basis for computing F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. and, if applicable, future budget periods.) Budgets should not exceed the direct costs Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (plus applicable F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.) previously recommended for any budget period. For transfers in the middle of a budget period, the budget for the initial year may be based on the total costs relinquished only if the recipient has been instructed to do so by the awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.. For these applications, recipients will also need to include the Other Project Information and the Senior/Key Personnel The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as Senior/Key Personnel. components.
Updated biographical sketches for the PD/PI and existing senior/key personnel and biographical sketches for any proposed new senior/key personnel.
If transferring on the anniversary date, include the progress report for the current year including a statement regarding the goals for the upcoming year. For all transfer applications include also a statement indicating whether the overall research plans/aims have changed from the original submission, and, if so, provide updated information.
Updated "other support" page(s), if necessary.
Resources page, including probable effect of the move on the project.
Checklist page
Certification of IRB/IACUC approval, including OHRP and OLAW assurance numbers, if applicable.
Detailed list of any equipment purchased with grant funds to be transferred to the new organization (inclusion of this list in the transfer application from the new organization indicates its acceptance of title to that equipment).

The electronic application from the proposed recipient institution should include, at a minimum, the following:

SF 424 (R&R) Cover Component
SF 424 (R&R) Project Performance Site Location(s)
SF 424 (R&R) Other Project Information:
- Certification of IRB/IACUC approval, including OHRP and OLAW assurance numbers, if applicable.
- Facilities and Other Resources, including probable effect of the move on the project.
- Detailed list of any equipment purchased with grant funds to be transferred to the new organization (inclusion of the list in the transfer application from the new organization indicates its acceptance of title to that equipment).
SF 424 (R&R) Senior/Key Person Profile:
- Updated biographical sketches for the PD/PI and existing senior/key personnel and biographical sketches for any proposed new senior/key personnel, and updated "other support" page(s) as necessary.
Budget pages applicable for activity code (current and future years). If the budget for the original award was submitted in a modular format, use the R&R Detailed Budget form for all electronic applications. Recipients may either complete all of the fields in the R&R Detailed Budget as appropriate or complete only the costs for the PD/PI (Section A), and include the remainder of the direct costs Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. under Section F (Other Direct Costs) Items 8-17, and Section H (Indirect Costs). (For awards resulting from modular applications, include narrative budget information for the current budget period, including total direct cost Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. and the basis for computing F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. and, if applicable, future budget periods.) Budgets should not exceed the direct costs Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. previously recommended for direct costs Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (plus applicable F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.) for any budget period. For transfers during the course of a budget period, the budget for the initial year may be based on the total costs relinquished only if the recipient has been instructed to do so by the awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award..
PHS 398 Research Plan
- If transferring on the anniversary date, include the progress report for the current year including a statement regarding the goals for the upcoming year. For all transfer applications include also a statement indicating whether the overall research plans/aims have changed from the original submission, and, if so, provide updated information.
PHS 398 Cover Page Supplement
PHS 398 Checklist

And, as applicable:

PHS Training Budget Form
PHS 398 Career Development Award Supplemental Form
PHS 398 Research Training Program Form
PHS Human Subjects and Clinical Trial Information Form
SBIR/STTR Information

NIH may request additional information necessary to accomplish its review of the request. 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 recipient organization by issuing a revised NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. to the original recipient reflecting 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 or the available balance in PMS, whichever is less.)

Concurrently, the new recipient will receive the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. reflecting the direct cost Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. balance reported on the relinquishing statement plus applicable F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived., if funds are available. If the change of recipient organization occurs on the anniversary date of the project, the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. to the new recipient will reflect the previously committed direct cost Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. level plus applicable F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. if funds are available. If the change of recipient organization occurs during the course of the budget period, the policy of the awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. will determine if the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. to the new recipient will reflect the direct cost Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. relinquished by the former recipient plus applicable F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. or the total costs relinquished by the former recipient. This amount is subject to change as a result of the closeout of the original grant and may be adjusted downward.

A recipient may, at its own risk and without NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements)., incur obligations and expenditures to cover costs before the beginning date of a transfer award. The recipient may do so only if those costs are necessary to conduct the project and would not require prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). if incurred under an awarded grant. For the purposes of pre-award costs, transfers are treated like non-competing continuation awards. Therefore, the pre-award costs incurred are not limited to 90 days prior to the beginning date of the initial budget period of that transferred award to the new recipient organization.

8.1.2.8 Change in Recipient Organizational Status

Recipients must give NIH advance notice of the following types of change in organizational status (not a change of recipient organization as described above):

Merger. Legal action resulting in the unification of two or more legal entities. When such an action involves the transfer of NIH grants, the procedures for recognizing a successor-in-interest will apply. When the action does not involve the transfer of NIH grants, the procedures for recognizing a name change normally will apply.
Successor-in-Interest (SII). 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 recipient or the transfer of that part of the assets involved in the performance of the grant(s). A SII may result from legislative or other legal action, such as a merger or other corporate change.
Name Change. Action whereby the name of an organization is changed without otherwise affecting the rights and obligations of that organization as a recipient.

Advance notification is required to ensure that the recipient remains able to meet its legal and administrative obligations to NIH, and payments are not interrupted.

Recipients are encouraged to contact the GMO of the lead NIH awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. to explain the nature of the change in organizational status and receive guidance on whether it will be treated as a name change or SII. The lead awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. ordinarily will be the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. with which the organization has the most NIH grants. NIH reserves the right to review the material provided, seek clarification or additional information, and make an independent determination.

A recipient's formal request for a change in organizational status 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 SII, a letter signed by the AORs of the current recipient (transferor) and the successor-in-interest (transferee) must be sent to the lead NIH awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award., following consultation with the GMO of that awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.. The letter must include the following:

Stipulate that the transfer will be properly affected in accordance with applicable law.
Indicate that the transferor relinquishes all rights and interests in all of the affected grants.
Request that the awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.(s) modify its (their) records to reflect the transferee as the recipient of record.
State the effective date of the transfer.
Provide the transferee's EIN. If EIN is new, include completed Form W-9.
Include verification of the transferee's compliance with applicable requirements (e.g., research misconduct Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. assurance of compliance).
Include a list of all affected NIH grants (active and pending) with the following information for each:
- Complete grant number (e.g., 5 R01 GM 12345-04).
- Name(s) of PD/PI(s).
- Current budget period and project period.
- The total direct costs Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (as originally recommended) plus applicable F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. for each remaining budget period. If the SII will occur during a budget period rather than on the anniversary date, the transferor also must provide estimated levels of current-year direct and F&A costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. remaining as of the SII effective date. The estimate may be reported on the PHS 3734 (Official Statement Relinquishing Interests and Rights in a Public Health Service Research Grant), which may be submitted on paper or electronically through the eRA Commons, or may be itemized by grant number as an attachment to the letter. When an SII occurs during a budget period, the deobligation of funds will be based on the estimated grant expenditures through the relinquishment date, as reported on the relinquishing statement or the available balance in PMS, whichever is less.
Include a complete face page (PHS 398) for each affected grant showing the transferee as the applicant organization. Each face page must be signed by an AOR at the transferee organization.
Include a copy of the current negotiated F&A rate agreement for the transferee.

Recipients may choose to submit an electronic application for a successor-in-interest request to satisfy the requirement for the face page(s), confirmation of the transferee's EIN, verification of the transferee's compliance with applicable requirements (e.g., research misconduct Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. assurance of compliance), and Relinquishing Statement. The electronic application is submitted via Grants.gov using the Parent Announcement.

In order to be recognized as the SII, the "new" (transferee) organization must meet each grant program's eligibility requirements; except for grants awarded under the SBIR/STTR programs. See Small Business Innovation Research and Small Business Technology Transfer Programs-Eligibility in IIB for additional guidance. Upon review and acceptance of this information, NIH will revise the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system.(s) to show the transferee as the recipient of record.

For name changes, the recipient's written notification to the lead NIH awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. must include the effective date of the change. Revised face pages are not required for name changes because name changes are reported and processed with the next award action (e.g., non-competing continuation award).

8.1.2.9 Deviation from Award Terms and Conditions, including Restrictions in the NoA

NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). is required for any deviation from terms or conditions stated or referenced in the NoA Notice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system., including those in the NIHGPS. This includes undertaking any activities disapproved or restricted as a condition of the award.

8.1.2.10 Foreign Component Added to a Grant to a Domestic or Foreign Organization

Adding a foreign component under a grant to a domestic or foreign organization requires NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements)..

8.1.2.11 Provide Subawards Based on Fixed Amounts

With NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements)., a pass-through entity may provide subawards based on fixed amounts (as defined in 2 CFR Part 200.201), to which the following conditions apply:

The Fixed amount subaward is negotiated using the cost principles The government-wide principles, issued by OMB (or, in the case of commercial organizations, the Federal Acquisition Regulation [48 CFR 21], or, in the case of hospitals, 45 CFR 75, Appendix IX, "Principles For Determining Costs Applicable to Research and Development Under Grants and Contracts with Hospitals"), on allowability and unallowability of costs under federally sponsored agreements. See Cost Considerations-The Cost Principles for additional details. (or other pricing information) as a guide. The pass-through entity may use fixed amount subawards if the project scope has specific measurable goals and objectives and if adequate cost, historical, or unit pricing data is available to establish a fixed amount subaward based on a reasonable estimate of actual cost. Payments are based on meeting specific requirements of the subaward. Accountability is based on performance and results. Except in the case of termination before completion of the subaward, there is no governmental review of the actual costs incurred by the non-Federal entity in performance of the subaward. Some of the ways in which the fixed amount subaward may be paid include, but are not limited to:

In several partial payments, the amount of each agreed upon in advance, and the "milestone" or event triggering the payment also agreed upon in advance, and set forth in the subaward;
On a unit price basis, for a defined unit or units, at a defined price or prices, agreed to in advance of performance of the subaward and set forth in the subaward; or,
In one payment at subaward completion.

A fixed amount subaward cannot be used in programs which require mandatory cost sharing or match.
The non-Federal entity must certify in writing to the pass-through entity at the end of the subaward that the project or activity was completed or the level of effort was expended. If the required level of activity or effort was not carried out, the amount of the subaward must be adjusted.
Periodic reports may be established for each fixed amount subaward.
Changes in principal investigator, project leader, project partner, or scope of effort must receive the prior written approval of the pass-through entity.

When considering the use of a fix amount subaward, note the distinction between a fixed-amount subaward and a fixed-rate agreement.

In a fixed amount subaward, the total value of the award is negotiated upfront. This requires the pass-through entity to know both the unit price and the total number of units that will be provided. In a fixed-rate agreement, while there is a negotiated cost per unit, e.g. per patient cost in a clinical trial (or participant in a non-Clinical Trial Human Subjects Study), the total amount of the award may be unknown when the agreement is created. Since this type of agreement is based on a "fixed rate" as opposed to a "fixed amount" as defined by 2 CFR Part 200.201, prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). is not required to enter into this type of agreement provided there are no other factors that would require NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). consistent with Transfer of the Performance of Substantive Programmatic Work to a Third Party by Means of a Consortium Agreement.

8.1.2.12 Need for Additional NIH Funding without Extension of Budget and Project Period

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 or renewal application or grant progress report for non-competing continuation support was submitted, is a non-competing supplemental application. Such requests must be submitted electronically, for both single and multi-project awards, and are not required to compete with other applications for funding. Other recipient-initiated requests for supplemental funding during a current budget period are considered to change the scope of the approved project and may be required to compete for funding with other applications. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget is adjusted at the time of award, and 2) use the institution's current F&A rate; i.e., the rate in effect when the new funding is provided.

8.1.2.13 Need for Additional NIH Funding with Extension of the Final Budget Period of a Project Period

A request for a non-competing extension of the final budget period of a project period with a minimal amount of additional funds should be submitted to the GMO, in writing, at least 30 days before the project period is scheduled to expire. Such requests usually are for a period of up to 12 months and must be either for work that remains to be completed on the project or to permit orderly phase-out of project activities for which there will be no further NIH support. Resources must be available to continue to support the project. The request must specify the proposed revised ending date and must include justification for both the extension and the additional funds requested. Special justification will be required for an extension that would exceed 12 months. NIH will not approve such requests if the primary purpose of the proposed extension is to permit the use of unobligated balances of funds. All terms and conditions of the award apply during the extended period.

All Federal agencies are required by 31 U.S.C. §1552(a) to close fixed year appropriation accounts and cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability, unless otherwise authorized by Congress. For NIH to meet its obligation to close these accounts and cancel any remaining balances by September 30, recipients must report disbursements on the FFR no later than August 31^st of the fifth fiscal year after the year of availability. At the end of five years, the funds are cancelled and returned to the Treasury. This provision may limit NIH's ability to further extend the final budget period with funding.

8.1.2.14 Pre-Award Costs

See Cost Considerations-Selected Items of Cost-Pre-Award (Pre-Agreement) Costs.

8.1.2.15 Rebudgeting of Funds from Trainee Costs

The rebudgeting of amounts previously awarded for trainee costs (stipends A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee., tuition, and fees) to other categories of expense requires NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements).. This excludes trainee travel, which NIH does not consider to be a trainee cost, and training-related expenses (see Ruth L. Kirschstein National Research Service Awards-Institutional Research Training Grants-Rebudgeting of Funds in IIB).

8.1.2.16 Rebudgeting of Funds Between Construction and Non-construction Work

Under awards that provide for both construction and non-construction work, NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). is required to transfer funds between the two types of work.

8.1.2.17 Retention of Research Grant Funds When a Career Development Award is Issued

Funds budgeted under an NIH grant for an individual's salary and fringe benefits, but available as a result of receiving a K award for that individual, may not be used for any other purpose without NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements)..


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