NIH Resources

NIH provides several different funding opportunity announcements (FOAs) for grants and cooperative agreements via support mechanisms which identify program specifications through activity codes. Each of the 27 NIH Institutes and Centers (ICs) utilizes a mix of these mechanisms to structure its research portfolio in accordance with their mission.  NIH also provides helpful information via eRA Modules, User Guides, and Documentation.

To find FOAs supported by NIH, please utilize the NIH Guide for Grants and Contracts to find opportunities pertinent to a PI's scientific field.

Please note: Not all ICs participate in every grant mechanism and program. It is important to review the FOA carefully to verify participating ICs and comply with all special instructions in order to develop a strong application.  

For Duke application submissions, please review the following information to facilitate a smooth submission.

 

Proposal Preparation

Instruction

  • Confirm FOA is still active and has not yet expired by checking the Key Dates section. It is common for FOAs to be reissued with updated information under a new opportunity number.
  • Most FOAs fall under the standard due dates for competing applications. Always refer to the FOA for accurate information regarding submission due date. In order for an electronic application submission to be considered on-time, it must be submitted by 5:00 p.m. institution local time and be received within the eRA Commons portal without any errors.
  • In order to ensure compliance with all NIH requirements in the preparation of an application, please review thoroughly the following material:
    • Funding Opportunity Announcement (FOA)
    • Electronic submission - SF424 (R&R) Application Guide or Paper submission - PHS 398 Instructions (links located in the NIH Resources section on the right column of this page)
    • NIH Grants Policy Statement (NIHGPS) and Notices to ensure no updates were issued which would impact the selected FOA submission (links located in the NIH Resources section on the right column of this page)

Budget Development

NIHGPS Cost Considerations should be followed during the budget development process. The FOA will identify the budgetary limits of the selected opportunity which may dictate caps on certain direct cost line items (e.g., travel), types of expenses (e.g., renovation), and overall funding limits (e.g., $275,000 in direct costs). Refer to Developing Your Budget for further details (link located in the NIH Resources section on the right column of this page).

Types of Budget

The type of budget utilized on an NIH application is determined by direct cost total requested and activity code applied.

  • Modular Budget - Format is utilized when the selected FOA indicates this budget type is mandatory or the  budget created has total direct costs allocated to the application equal to or less than $250,000 per year (total direct cost calculation DOES NOT include consortium/subaward F&A costs).   Please note: SBIR and STTR applications DO NOT accept the modular budget format. Refer to Developing Your Budget and NIH Modular Research Grant Applications for further details (links located in the NIH Resources section on the right column of this page).
  • Detailed (Traditional) Budget - Format is utilized when the total direct costs applied exceed $250,000 in any requested year. If the direct cost calculation requested in any year is equal to or greater than $500,000, prior approval will be required from the NIH before application submission. Please refer to NIH Guide Notice NOT-OD-02-004 for further information. A cover letter will become mandatory to provide in the application indicating prior approval received for the $500,000 level in order to be accepted by the Center for Scientific Review at time of submission receipt. Please note: If the selected FOA indicates a specific budgetary level which would accept this level, the FOA will override the prior approval requirement.

Personnel 

  • PIs and postdoc roles must have an eRA Commons PI account with Duke University as the affiliation regardless of submission method. Refer to How to create a PI Account in eRA Commons for further details.
  • PI eligibility requirements are addressed in FOAs and should be reviewed for individual compliance. For institutional compliance with PI status and/or Multiple PI applications, please refer to the PI Status page.
  • PI Effort Level: When the FOA and/or activity code requires an effort level requirement for the PI role, the required effort level must be committed for the PI in each budget year of the grant. When no effort level requirement is addressed by NIH, PIs must commit a minimum effort that is measurable/greater than zero (eg 0.01 or .1 calendar months) to demonstrate effort in accordance with Duke School of Medicine policy (Exception: PIs performing the Mentor role on a grant or when support mechanism is for a construction, conference, or instrumentation grant).
  • Effort: When personnel are identified for a role on the budget, the effort level must be represented in person months. Refer to the Effort Conversion Table in the Duke Guidance Documents section for further assistance.
  • Salary Cap: NIH will not pay for any salary requested above the annual salary cap. For those faculty members whose Institutional Base Salary (IBS) exceeds the salary cap level, the cap will need to be applied. Refer to the Salary Cap Worksheet for salary cap calculation assistance and the Sample of Salary Cap Cost Sharing in SPS for understanding how to apply the salary cap in the SPS system in the Duke Guidance Documents section of this page.

              For additional clarification on the NIH Salary Cap, please use the Award Scenario Matrix.

  • Senior/Key Personnel: Individuals who contribute to the development or execution of the science in a considerable and measurable way may be designated as Key by the PI regardless of whether or not the individual receives salary support from NIH. To clarify, all individuals who are identified as Key MUST have effort associated to their role. Duke PIs may identify Key personnel within the SPS record Personnel Roster Notebook Roster tab.
  • The Other Significant Contributors (OSCs) role allows individuals to contribute to the development of the science on an as needed basis. As a result, this role has no measurable effort and no salary support as their contribution cannot be measured consistently.  A biographical sketch is required for OSCs to demonstrate their expertise relevant to the application. Duke PIs may identify OSCs within the SPS record Personnel Roster Notebook Roster tab.
  • Individuals who have a dual appointment with the Veterans Administration Medical Center (VAMC) will need to provide a Memorandum of Understanding (MOU) reflecting their appointment at the VA. For further information and assistance, please refer to the VA Partnerships page.

Budget Justification

  • Modular budget justifications should include the following:
    • Personnel Justification - The name, role, effort level in person-months devoted to the project (as well as VA appointment if applicable) should be provided for every individual listed on the project. While detail of salary level and fringe benefit rate is not to be included, it is important to still consider the NIH salary cap as part of the modular calculation.
    • Consortium Justification - When working with a subrecipient site, it is important to include the subrecipient's budget justification on a modular application. The subrecipient should provide the prime organization with their modular budget and corresponding justification. Please ensure the subrecipient has included the total costs with a break down between direct costs and F&A costs rounded to the nearest $1,000. The same personnel description details should be adhered to as the personnel justification above.
    • Additional Narrative Justification: If there is any variance in modules over the years of the performance period, the narrative justification will become mandatory. This section would also include direct costs that are excluded from indirect (F&A) costs (e.g., tuition remission, patient care). Foreign activity or any off-site F&A towards the scope of work would also need to be included.  
  • Detailed budget justifications should include the following:
    • Narrative explanation for each item for each year matching amounts indicated on the budget
    • Personnel should indicate role, effort level (if Key individual effort level is required), salary caps, and fringe benefits

​Subawards

When there is a subrecipient site on the project, the site will need to follow the budget of the prime organization. Therefore, if Duke were the prime organization submitting a modular budget, the subrecipient site would also have to submit a modular budget. At the application stage, the department should collect a signed PHS 398 face page, budget, budget justification, scope of work, resources page, and checklist page (please remember foreign sites will need to apply 8% F&A limitation). If the application was selected for JIT request, the subrecipient would need to provide the standard JIT components in accordance with the request (e.g., Other Support) as well as a completed Duke Subrecipient Checklist (Form Page 1). If the application was awarded, a Duke Subrecipient Checklist (Form Page 1) would need to be collected with each progress report cycle to comply with subrecipient monitoring.

Escalation of Costs in Out Years

  • NIH will provide up to a 2% escalation factor for recurring costs applied to future budget periods. Remember the adjustment on salaries cannot exceed the salary cap. Refer to NIH Guide Notice NOT-OD-11-068 for further information. Please note: To complete the budget in SPS to reflect this escalation accurately, a manual adjustment will need to be performed within the SPS Budget Notebook Rules tab to the Period Definition box Personnel and Operations Inflator columns from 3% to 2%.
 
Research Plan
  • Page Limits: There is a page limit for research plan sections on NIH applications arranged by activity code. If the FOA indicates a specific page limit, it will override this table of page limits. Therefore, please review the selected FOA carefully for special page criteria exceptions.

 

Submission Process

Applicant Organization Registration Completed: Duke University is registered as an applicant organization with both Grants.gov and eRA Commons. This one-time registration is complete with no further action necessary.

For electronic applications at Duke there are two possible submission methods:

Grants.duke:

  • This web app provides the DUMC community the ability to submit grant proposals electronically to NIH. The Sponsored Projects System (SPS) populates the Grants.duke system to allow users to attach supporting documents to the grant proposal, then release the proposal for submission. Grants.duke electronically transmits the proposal to Grants.gov, then on to eRA Commons for NIH receipt.
  • The Grants.duke system may be updated with application documents once the corresponding SPS record is at an Initialized state.
  • The SPS record must be completed and routed to the Pending Central Approval (PCA) state 7 business days prior to the application due date. SPS records received after this timeline will require a waiver. Please refer to the Grant Proposal Waiver Request page.
  • Once the SPS record has received an approved ORA review, the record will be changed to the Awaiting Submission state which allows the PI to release / submit the application to NIH in Grants.duke. PIs will need to submit applications by 5:00 p.m. institution local time for receipt at eRA Commons without any error to be considered on-time.

Grants.gov: 

  • When an FOA is NOT supported by Grants.duke, a Grants.gov package will need to be completed and attached to the SPS record Internal Documentation. Please note: Grants.gov packages can expire in connection with an FOA. It is VERY important to confirm on the first page of the downloaded package that the expiration date has not passed and it remains active. Expired packages will not pass the validation process of electronic submission.
  • The SPS record will have no connection to the Grants.gov package and will require additional time for separate data entry.
  • The SPS record must be completed and routed to the Pending Central Approval (PCA) state 7 business days prior to the application due date which includes the Grants.gov package as an attachment in the SPS Internal Documentation.
  • It is acceptable for the Grants.gov package to have all administrative sections complete with the Research Plan still outstanding at this stage of ORA review.
  • ORA will review the application and will expect to receive the Research Plan components 2 business days prior to the application due date. Upon receipt of the completed Research Plan components, ORA will submit the application through the Grants.gov portal by 5:00 pm. institution local time for receipt at eRA Commons without any errors.
 

Please note: Electronic application submissions must comply with the error correction window change which does not allow corrections or modifications after the deadline due date / time. Refer to NIH Guide Notice NOT-OD-10-123 for further information.

If it is uncertain whether the selected FOA is Grants.duke eligible, please contact your assigned ORA Grants Specialist for confirmation.

For paper submissions the ORA office will need the SPS record completed and routed to the PCA state 7 business days prior to the application due date. Upon an ORA approved review, ORA will sign off on the appropriate forms as the authorized organization representative (AOR) and inform the department when the signed forms will be ready for pick up at the front desk.

Please refer to NIH Submission Policies for further details (link located in the NIH Resources section on the right column of this page).

Example for determining 7 business day calculation to meet ORA submission guideline:

NIH June 15th deadline

ORA 7 business day timeline would fall on June 6th by 8:00 a.m. for SPS record to be completely routed to the Pending Central Approval (PCA) state in order to be received in ORA Specialist SPS in-box on June 6th. Please note: The Show History screen within SPS indicates which user is reviewing the record for approval. When record is routed to a Pending Non-Central Approval (PNCA) reviewer, the record will remain in that Non-Central reviewer's in-box for two days and will auto advance if no action is applied to the record in that time frame. Refer to FY 2011 ORA Timeline for NIH Submission Cycle in the Duke Guidance Documents section on this page for further guidance.

 Sunday  Monday  Tuesday  Wednesday  Thursday  Friday  Saturday
  3   4   5   6   7   8   9
 10  11  12  13  14  15  16
 

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Award Selection & Post Award Administration

 
Pre-Award Selection

Peer Review Process: Once an application is received within the eRA Commons and upon acceptance by the Division of Receipt and Referral (DRR) within the Center for Scientific Review, it receives a grant assignment number and undergoes two separate stages of review. The first review is conducted by a Scientific Review Group (SRG) consisting generally of non-federal scientists with expertise in the pertinent research area and scientific field. The second review is executed by the Institute and Center (IC) National Advisory Councils or Boards. Recommendation of funding occurs only when both reviews favorably approve the application.

Just-In-Time (JIT): A request for JIT information by NIH indicates that an application has been recommended favorably in the dual peer review system and is in contention for consideration of award. When an application receives a fundable score, the JIT function will become available under the action column within eRA Commons. This electronic step does NOT indicate a JIT request has been made by NIH. PIs will receive notification of JIT request via e-mail and/or phone from NIH staff. Upon receipt of JIT request, SPOC approved Other Support documents for all designated key personnel, certification of IRB and/or IACUC concordance approval (as applicable), and human subjects (CITI) training certification for all key personnel (as applicable) should be sent via e-mail to the assigned ORA Grants Specialist for review and submission. It is recommended to respond to a JIT request within a 2 week time frame unless a due date is specifically stated by NIH. Please keep in mind documentation provided to ORA will be placed into a queue unless priority is addressed when the documentation is provided. ORA will perform the review of the documentation,  and, upon approval, will upload certified documents into the JIT feature and submit the JIT documentation. 

Pre-Award Spending: When a  grant application has received favorable consideration with communication indicating award, a department may submit a Cost Object Request Form to their assigned ORA Grants Specialist to establish a WBS Element / Fund Code for pre-award spending. NIH allows costs to be encumbered in the pre-award spending window of 90 days before the beginning date of the initial grant budget year for new (Type 1) or renewal (Type 2) when they are necessary and allowable towards the development of the grant. Departments provide a back-up WBS Element / fund code on the Cost Object Request Form with the understanding this preliminary spending is at their own risk for expenses drawn until an actual Notice of Award is released by NIH to obligate funds on the selected grant.  Please note: It is important to confirm the selected grant may utilize pre-award spending as not all support mechanisms allow it.

Post Award Administration

Notice of Award: NIH provides notification to ORA when Notice of Awards (NoAs) are received and released within the eRA Commons system. The NoA serves as the legal document initiating the period of support, amount of funds obligated in the initial budget period, identification of Sponsor key personnel (noted in Section IV in addition to PI), any restrictions on the use of funds (also noted in Section IV), and anticipated amounts of support for the out years of the project period (when applicable).

Rebudgeting: NIH allows the rebudgeting of funds as long as the threshold of change between single direct cost budget categories does not increase or decrease by more than 25% of the total costs awarded from the original budget category commitment level stated in the budget period. If the change of budget categories exceeds 25%, NIH prior approval will be necessary as it will be considered a change in scope of work. Departments may submit a rebudgeting request form to their assigned ORA Grants Specialist for review and approval.

NIHGPS Prior Approval: The NIH Grants Policy Statement provides the Prior Approval Requirements section which informs NoA recipients when approval for certain actions and / or disbursement will need to involve NIH.  Departments may send requests signed by the PI for NIH Prior Approval via e-mail to their assigned ORA Grants Specialist. ORA will countersign the request letter upon approved review and will submit to NIH to obtain approval. Please note: NIH specifications regarding prior approval submissions are addressed in the NIHGPS and indicate requests should be sent to NIH at a minimum of 30 days prior to the effective date of the needed change.

Non-SNAP Progress Reports: SNAP (Streamlined Non-Competing Award Process) eligibility is addressed in Section III of the NoA. When a progress report does not fall under SNAP it is due 60 days prior to the next grant year budget period start date. PHS 2590 Non-Competing Grant Progress Report Instructions and Forms will need to be completed manually for paper submission to NIH. Refer to the RPPR page for those awards that are SNAP eligible.

  • SPS record at PCA state for ORA receipt must occur 7 business days prior to the 1st of the month Non SNAP report deadline which includes SPOC certified Other Support (OS) documents for all Duke key personnel attached within Internal Documentation. Please note: It is helpful to provide SPOC certified OS documents as soon as possible to ensure there is enough time for ORA to queue certifications into workload to meet the deadline.
  • NIH progress reports for non-SNAP awards must be submitted in hard copy to the centralized mailing address below:
            Division of Extramural Activities Support, OER
            National Institutes of Health
            6705 Rockledge Drive, Room 2207, MSC 7987
            Bethesda, MD 20892-7987 (for regular or US Postal Service Express mail)
            Bethesda, MD 20817 (for other courier / express mail delivery only)
            Phone Number: (301) 594-6584
 

Supplements (Revision Type 3 applications): When a PI submits a supplement or revision application, it is to request additional funds for a specific use to expand the scope of work of an existing Type 1, 2, or 5 award.

  • Confirm the submission method of paper application (PHS 398 forms) or electronic application (SF424 R&R Forms) by FOA review or from the assigned NIH Program Official.
  • Supplement title will need to remain the same as the parent award.
  • An SPS record will need to be completed and routed to PCA state for ORA receipt 7 business days prior to the deadline date of the supplement application.
  • When a supplement is awarded, it is considered a restricted award; therefore, a new WBS Element / fund code will need to be initiated separate from the parent award to ensure funds encumbered on the supplement are for the intended purpose proposed.   
 

No Cost Extensions: NIH allows NoA recipients a ONE-TIME authority to extend their grant up to 12 months (may request by month increments anywhere from 1 to 12 months) from the original expiration date stated in the NoA without additional funds obligated to the award. Please note: No Cost Extensions (NCE) are allowed under expanded authority as part of the NIH Standard Terms of Award when there is no change in scope, NoA special terms and conditions do not restrict authority, and activity code permits extensions (i.e., Fellowship F series does not allow NCE).

Criteria for NCE 

  • More time is needed beyond the awarded expiration date to adequately complete the original aims approved for the grant
  • Continuity of support for existing award while renewal (Type 2 competing continuation) is going through the review process
  • Additional time is necessary to phase out the grant in order to closeout the aims
 

First NCE Request Submission Process

  • A first NCE submission is electronically performed by the No Cost Extension function via eRA Commons. The NCE feature becomes available within the eRA Commons system 90 days prior to the original awarded expiration date. An NIH No Cost Extension Request Form (located in the Duke Guidance Documents section of this page) will need to be completed and submitted via e-mail to the appropriate / assigned ORA Grants Specialist at least 10 days prior to the original expiration date to accommodate a review and approval of extension action. As only individuals with the Signing Official (SO) role may submit extensions in the eRA Commons system, an ORA director will process the extension action. Once the extension action is performed, eRA Commons will automatically update the project and budget period to the new extension end date.
  • If the original awarded end date was missed without NCE action and it is needed retroactively, a letter will need to be created indicating the NCE request new end date signed by the PI and sent via e-mail to the appropriate / assigned ORA Grants Specialist to review and approve with ORA countersignature. ORA will submit letter to the assigned NIH Grants Management Specialist for extension approval.
 

Second and Third NCE Request Submission Process

  • A letter will need to be generated and signed by the PI for submission to ORA for countersignature. ORA will submit the letter to NIH for approval. The request for extension should be submitted to NIH at least 30 days prior to the current NCE project period expiration date to comply with NIH specifications. There are more requirements to include in the second and third request for extension. Please ensure the following information is provided to receive approval:
  1. Indicate the estimated unobligated balance amount remaining on the grant
  2. Incorporate the unobligated balance amount level into a detailed budget to demonstrate how remaining funds will support the proposed plan for extension
  3. Address effort levels for Key Personnel during the requested extension period
  4. Provide updated active approval certifications for IRB and/or IACUC protocols as applicable to human subject and vertebrate animal involvement
  5. Indicate the scientific rationale for project continuation
  6. Provide a detailed justification as to why the project will require more time to finalize from the approved end date
 

A remaining balance of funds at time of project period expiration does NOT serve as an adequate stand alone justification for NCE. Please refer to the Criteria for NCE for guidance on acceptable instances for NCE. 

Terms and Conditions during the Approved No Cost Extension Period

  • All terms and conditions addressed in the NoA and stated in the NIHGPS remain in effect during the extension period.
  • Current approved effort levels for Key Personnel remain in effect during the extension period. If a significant reduction of effort is needed for a key person on the grant, it will be considered a Change in status requiring NIH prior approval in accordance with the NIHGPS Prior Approval Requirements.
 

Closeout: The following documentation becomes required to closeout an NIH award within a 90 calendar day window after the project period end date:

  1. Final Federal Financial Report (Duke Office of Sponsored Programs responsible for submission)
  2. Final Progress Report
  3. Final Invention Statement and Certification
 

Closeout Submission Process

  • While NoA recipients may submit the non-financial closeout documentation via e-mail to the NIH Central Closeout Center or by paper submission via mail or fax to the NIH Central Closeout Center, it is recommended to utilize the Closeout function within eRA Commons. Refer to the ORA NIH Closeout Process in the Duke Guidance Documents section of this page.

 

Duke Guidance Documents