Prior Approval Requests

The NIH Standard Terms of Award provide the recipient the authority to extend the final budget period one time for a period of up to 12 months (1st no-cost extension) beyond the original completion date in the Notice of Award (NoA).

The NIH requires Prior Approval for no-cost extensions once a project has passed the project period end date (at this time the recipient is no longer able to request the first extension through the eRA Commons) or if the recipient is requesting to extend the project past the end of the 1st no-cost extension period.

Prior approval for a 2nd no–cost extension can be requested if there are significantly justifiable reasons why the research is interrupted and is not progressing as planned.  

A no-cost extension only extends the time of the award. It does not provide additional funding.

Change of the Principal Investigator (PI) or Program Director (PD); or Key Personnel; or from single to multiple PIs (or vice versa) named in the NoA requires prior approval from the awarding NIH IC. A “change of PI” is the process by which the primary PI (or another key personnel named in the NoA) can no longer carry-out the duties of the grant award and another investigator will take over responsibility. The request for a “change of PI” must be submitted by an authorized AOR/SO at the recipient organization, no later than 30 days prior to the proposed change.

If the arrangements proposed by the recipient organization, including qualifications of any proposed replacement, are not acceptable to the NIH awarding IC, 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 the NIH will forward closeout instructions.

Please note that the requirement to obtain NIH prior approval for a change of PI or Key Personnel pertains only to those personnel NIH designates in the NoA, regardless of whether the recipient organization designates others as Key Personnel for its own purposes.

Change in the effort of the PI/PD or other Key Personnel named in the NoA requires prior approval from the awarding NIH IC when the effort level devoted to the project changes by 25 percent or more from what was approved in the initial competing year award; or if the PI/PD is absent for any continuous period of 3 months or more. This can occur for a variety of reasons (e.g., retirement, change of employment, sabbatical etc.) The request for a change of effort must be submitted by an AOR/SO at the recipient organization, no later than 30 days prior to the proposed change.

Please note that the requirement to obtain NIH prior approval for a change in status pertains only to personnel NIH designates in the NoA, regardless of whether the recipient organization designates others as Key Personnel for its own purposes.

A change of institution involves the transfer of the legal and administrative responsibility for grant from one legal entity to another.

NEI expects to be notified at least three months prior to the date of transfer. Any notification after this time could cause delays that could adversely impact research. Transfer applications that come in close to the end of the fiscal year may be deferred for processing until the next fiscal year. A complete request is needed in order for NEI to transfer a grant from one organization to another. The process must be  initiated by the AOR/SO of the institution that currently holds the award by submitting a Relinquishing Statement in eRA Commons and identifying the institution that will assume responsibility for the grant. This must occur well before the current approved project period expires.

Carryover is the process by which recipients carry forward unobligated funds to cover allowable costs in the current budget period. Most grants have automatic carryover authority, and recipients do not have to request approval from the NEI to carryover funds from one budget period to the next.

Recipients of awards that do not have automatic carryover authority indicated in Section III in the NoA grantees must request prior approval in writing from NEI to carry over funds. Some examples include but are not limited to: Cooperative Agreements (U01, UG1), Research center grants (P30), Training grants (T32, T35) and Fellowships (F30, F31, F32).

Carryover requests must be limited to actual needs for the current budget period. Budgetary overlap (duplicative or equivalent costs approved for the current budget period) is not allowed and should not be requested.

In general, the recipients may make changes in the methodology, approach, or other aspects of the project objectives. The recipient, however, must obtain prior approval from the NIH awarding Institute or Center (IC) for a change in scope. A change in scope is a change in the direction, aims, objectives, purposes, or type of research training, identified in the approved project.

Recipients are highly encouraged to contact their assigned PO and GMS prior to initiating actions that are potential indicators of a change in scope to determine whether prior approval is necessary. Failure to obtain required prior approval from NEI may result in the disallowance of costs, termination of the award, or other enforcement action within NIH's authority.

Please refer to the NIH Grants Policy Statement (8.1.2) for a list of Potential Indicators of a Change in Scope.

Recipients are permitted to rebudget between budget categories within the total costs awarded to meet unanticipated requirements, provided the expenditures: (1) Are within the scope of the approved project; (2) Enhance and do not impede the successful continuation or completion of the project; and (3) Are allowable under governing regulations and policies. The NIH Grants Policy Statement and the terms of the award should be consulted regarding current policies on rebudgeting and prior approval authority. The GMS assigned to the project may also be contacted for advice.

Scenarios where prior approval is always needed are:

1. The rebudgeting of amounts previously awarded for trainee costs (stipends, tuition, and fees) to other categories of expense requires NIH prior approval. This excludes trainee travel, which NIH does not consider to be a trainee cost, and training-related expenses.
2. 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.
3. 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.
4. Purchase of a unit of equipment exceeding $25,000, resulting in a change scope.
5. Significant rebudgeting in a single direct cost budget category that deviates (increase or decrease) from the categorical commitment level established for the budget period by 25 percent or more of the total costs awarded, resulting in a change in scope.
6. Incurrence of research patient care costs if costs in that category were not previously approved by NIH.
7. If a recipient desires to rebudget funds into or out of the research patient care category.

Revisions to an Approved Data Management and Sharing (DMS) Plan 

Under the final NIH Policy for Data Management and Sharing (DMS Policy), effective for applications submitted after January 25, 2023, NIH requires a recipient to comply with the DMS Plan as approved by the funding NIH Institutes, Centers, and Offices (ICOs). If DMS Plan revisions are necessary (e.g., new scientific direction, a different data repository, or a timeline revision) DMS Plans should be updated by recipients and reviewed and approved by the NIH Institutes, Centers, and Offices (ICOs) per NOT-OD_23-185.

Adding, changing, or transferring work to involve a foreign component requires prior approval from the awarding NIH IC.  This includes the addition of a performance site or research project in a country other than that specified in the competing application and/or a change in the performance site within a foreign country.  The request for adding or changing a foreign component must be submitted by an AOR/SO at the recipient organization, no later than 30 days prior to the proposed change. 

In accordance with the NIH Grants Policy Statement, a foreign component is defined as the performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended.  

Activities that would meet this definition include, but are not limited to, the following: 

• The involvement of human subjects or vertebrate animals at a foreign site; 

• Extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities; and/or 

• Any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. 

Examples of other grant-related activities that may be significant are: 

• Collaborations with investigators at a foreign site anticipated to result in co-authorship. 

• Use of facilities or instrumentation at a foreign site; and/or 

• Receipt of financial support or resources from a foreign entity. 

Foreign travel for consultation and/or conference attendance is not considered a foreign component.  

Recipients are highly encouraged to contact their assigned PO and GMS to discuss any plans for adding or changing a foreign component before submitting a prior approval request.  Failure to obtain required prior approval from NEI may result in the disallowance of costs, termination of the award, or other enforcement action within NIH's authority. 

References 

NIH GPS, Chapter 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components 

For no cost extensions (once a project has passed original project end date), please submit via Prior Approval Module (Prior Approval Module) and include:

1. Justification for the extension and why the work could not be completed as originally proposed
2. Dates for the proposed extension
3. Detailed budget and budget justification
4. Statement that there will be identification of other sources of funding to assist in the completion of the goals if the current balance is not sufficient (if this does not apply, simply state “no identification of other funding sources will be needed
5. Progress report summary
6. Publications or manuscripts accepted for publication in a journal or other publication (e.g., book, one-time publication, monograph) during the reporting period resulting directly from this award)
7. Anticipated unobligated balance on xx/xx/xxxx (current project period end date)
8. Confirmation that the appropriate assurances remain in place, and copies of current IRB or IACUC approvals, if appropriate

For Change of PI, please submit via the Prior Approval Module (Prior Approval Module) and include:

1. Justification for the proposed change
2. Biographical sketch of the individual proposed
3. Other support information of the individual proposed
4. Effort contributing to this project of the individual proposed
5. Any proposed changes in scope
6. Any budget changes resulting from the proposed change
7. Certification of Human Subjects Protection Training of the individual proposed, if applicable
8. Certification of Good Clinical Practice Training, if applicable
9. Multi-PI leadership plan, if applicable

For change of Key Personnel (listed on the Notice of Award), please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award and include:

1. The complete grant number and PI/PD
2. Justification for the proposed change
3. Biographical sketch of the individual proposed
4. Other support information of the individual proposed
5. Effort contributing to this project of the individual proposed
6. Any proposed changes in scope
7. Any budget changes resulting from the proposed change
8. Certification of Human Subjects Protection Training of the individual proposed, if applicable
9. Certification of Good Clinical Practice Training, if applicable

For change in effort of Key Personnel (listed on the Notice of Award, when the reduction is 25% or more from the originally approved level of effort), please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award and include:

1. The complete grant number and PI/PD 
2. Justification for the proposed change
3. Proposed effort level for the Key Personnel
4. Impact on the project

For change of institution (recipient organization), please submit documentation electronically via the eRA Commons.

FROM THE ORIGINAL INSTITUTION
The original institution must submit an Official Statement Relinquishing Interests and Rights in a Public Health Service Research Grant (PHS 3734). The preferred method of submission for the relinquishing statement is electronically via the eRA Commons.

FROM THE NEW INSTITUTION
A change of institution application may be submitted electronically via Grants.gov using the program announcement listed at PA-21-268 (or its reissuances): Change of Recipient Organization (Type 7 Parent Clinical Trial Optional) (nih.gov)

The electronic application from the proposed recipient institution must include the following:

1. SF 424 (R&R) Cover Component
2. SF 424 (R&R) Project Performance Site Location(s)
3. SF 424 (R&R) Other Project Information:
4. Certification of IRB/IACUC approval, including OHRP and OLAW assurance numbers, if applicable.
5. Detailed list of any equipment purchased with grant funds to be transferred to the new organization.
6. Facilities and Other Resources, including probable effect of the move on the project.
7. 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 key personnel, and updated "other support" page(s) as necessary
8. R&R Detailed Budget pages applicable for activity code (current and future years).
   1. 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 under Section F (Other Direct Costs) Item 8, and Section H (Indirect Costs). (For awards resulting from modular applications, include narrative budget information for the current budget period, including total direct cost and the basis for computing F&A costs and, if applicable, future budget periods.)
   2. For transfers during the course of a budget period, the budget for the initial year may be based on the total costs relinquished.
   3. Budgets should not exceed the direct costs previously recommended for direct costs (plus applicable F&A costs) for any budget period.
   4. If the grant currently includes salary support for the PI or any other transferring member of the project and continued salary support is not required at the new institution, a statement regarding the proposed rebudgeting of these funds is required
9. PHS 398 Research Plan
   1. 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. Please note revisions to Sections E. “Human Subjects Research” and F. Vertebrate Animals” of the research plan must be submitted.
10. F&A Rate Agreement: submit the current effective rate agreement for your institution and consortium partners, if applicable
11. Education in the Protection of Human Subjects: For all personnel responsible for the design or conduct of the study http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
12. PHS 398 Cover Page Supplement

For carryover requests, please submit via the Prior Approval Module (Prior Approval Module) and include:

1. Detailed programmatic justification for use of carryover funds, including any proposed change of scope
2. Detailed categorical budget for proposed carryover funds
3. Budget and budget justification
4. Explanation as to why the work cannot be accomplished through rebudgeting of funds awarded for the current budget period
5. Other Support: verification that any proposed increase effort by the PI and other Key Personnel will not cause budgetary overlap

For Change of Scope request, please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award:

1. The complete grant number and PI/PD
2. Justification for the proposed change
3. Revised Aims and/or Program Plan using the template (see GPS 2.5.2):
   1. Modified Project Summary/Abstract Section—If the abstract will be modified, provide the modified abstract in this section. If the abstract will not be modified, state “none.”
   2. Modified Specific Aims Section—If one or more Specific Aims will be modified, list the complete Specific Aims modification(s) in this section; up to one page is recommended. If the Specific Aims will not be modified, state “none.”
   3. Modified Public Health Relevance Section (Project Narrative)—If the project narrative will be modified, provide two or three sentences to modify the Project Narrative. If the project narrative will not be modified, state “none.”
4. Budgetary implications to the grant or cooperative agreement
5. Revised budget pages including budget justification (SF-424 format), if applicable
6. In addition, as applicable:

For Adding Human Subjects, please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award:

1. PHS Human Subjects and Clinical Trials Information using the following SF-424  forms:   
   • Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption
   • PHS Human Subjects and Clinical Trials Information
   • Study Record: PHS Human Subjects and Clinical Trials Information
   • PHS Inclusion Enrollment Report
2. Human Subjects Education Requirements: Please provide a statement confirming all personnel responsible for the design or conduct of the study have completed the required training. Information regarding this certification can be found in the NIH Guide to Grants and Contracts, June 5, 2000: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. Information on the NIH online tutorial can be found in the NIH Guide to Grants and Contracts, February 29, 2008: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.html.

For removing Human Subjects, please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award

1. Justification for the proposed change

 

For Adding or Substituting Animal Subjects, please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award

1. Justification for the proposed change
2. Vertebrate Animals Section. See the NIH Worksheet for Applications Involving Animals or the OLAW website: Vertebrate Animals Section for guidance and an example of a Vertebrate Animals Section.
3. PHS 398 Cover Page Supplement/PHS Fellowship Supplemental Form (SF-424 format)
4. Animal Welfare Assurance #
5. IACUC approval memo from your institution’s IACUC review
6. Budgetary implications to the grant or cooperative agreement
7. Revised budget pages including budget justification (SF-424 format), if applicable

 

For Removing Animal Subjects, please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award

1. Justification for the proposed change

For rebudgeting requests, please submit via e-mail to the Grants Management Specialist and Program Officer assigned to the award:

1. The complete grant number and PI/PD
2. Justification for the proposed change 
3. Revised budget pages including budget justification (SF-424 format)
4. If no Change in Scope, nothing further is needed
5. If a Change in Scope exists, please follow the instructions listed under Change in Scope above

For Revisions to an Approved Data Management and Sharing (DMS) Plan, a request must be submitted via the Prior Approval Module (Prior Approval Module).
Recipients must Select “Prior Approval – Other Request” and follow the instructions provided below to complete the required entry. Emails and other communications are not acceptable. The request must include the following:
 

1. Description: Enter “DMS Plan Revision” (without quotations).
2. Effective Date: Enter the effective date of the requested changes.
3. Justification Document: Identify and provide the rationale and justification for the requested changes.
4. Budget Document: Provide if the revised DMS Plan impacts the budget. Include information for current and future budget periods. Note: This is not a supplement request. Please provide confirmation that funds are available to re-budget and cover these costs. If supplemental funds are necessary a separate supplement request is required (per Post Award budget consideration guidance).
5. Other Supporting Documents: Attach the revised DMS Plan.
6. Confirmation that there is no Change in Scope. If a Change in Scope exists, please follow the instructions listed under Change in Scope above.

All uploaded documents must be in PDF format.

Resources

• NIH Data Sharing Website
• Writing a Data Management & Sharing Plan - Applications for Receipt Dates ON/AFTER Jan 25 2023
• Frequently Asked Questions

For steps and screenshots, please see the Prior Approval Request section of the eRA Commons online help following the release.

For the addition of or change in foreign component, please communicate the anticipated change to the Grants Management Specialist and Program Officer assigned to the award via e-mail. You will receive an automated e-mail requesting the following information for review:  

1. Collaborator’s Name, Phone Number and E-mail Address 

2. Name and Address of the Foreign Site 

3. Estimated total costs of the Foreign Component/Site (if/any) for each year 

4. Brief narrative that includes description of the work that will be performed at each foreign site 

5. Is there Human Subject involvement? 

6. Is the FWA pending or established? 

7. Is there Animal involvement? 

8. Is the Animal Assurance pending or established? 

9. Is there foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities? 

10. Is there any activity that may have an impact on U.S. foreign policy through involvement in the affairs of environment of a foreign country? 

11. Is the collaboration with investigators at the foreign site anticipated to result in co-authorship? 

12. Will there be receipt of financial support or resources from a foreign entity?