REVISED OCTOBER 2018. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2018

Policies affecting applications, policy, direct cost limit, direct cost limitation, consortium/contractual F&A costs, $500000, resubmission of unfunded RFA Applications, new investigators and early stage investigators, ESI, PD/PI, postsubmission grant application materials, requirements, DUNS, SAM, graduate student compensation, NIH genomic data sharing, non-traditional application materials

2.3.7 Policies Affecting Applications

Application information to be submitted typically includes a project description, budget and budget justification, biographical sketches of senior/key personnel, and other information specified in the application instructions, in the announcement, and/or in program guidelines, if any. Applicants should consult the cost principlesThe 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. and general administrative requirements for grants pertaining to their organizational type in order to prepare the budget and complete other parts of the application. This section describes NIH policies that affect application preparation and/or submission. Specific details on application content are addressed in application instructions and specific FOAs. Any significant change to the application post-submission must be reported immediately to the appropriate NIH official.

2.3.7.1 Applications That Include Consortium/Contractual F&A Costs

For FOAs that include a direct costCosts 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. limit, NIH policy excludes consortium/contractual F&A when determining if an applicant is in compliance with the direct costCosts 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. limitation. This policy extends to all solicited and investigator-initiated applications and to all active announcements (Request for Applications and Program Announcements), involving consortium/contractual F&A costsNecessary 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., regardless of budget amount or budget format (e.g., modular and non-modular). While consortium F&A costsNecessary 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. may be requested and awarded, applicants should not consider these costs when determining if a budget exceeds a direct costCosts 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. limit.

This policy impacts eligibility to submit a modular budget. The modular budget format is used for applications requesting $250,000 or less in direct costsCosts 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. per year. Consortium/contractual F&A costsNecessary 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. are not factored into this direct costCosts 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. limit; however, they may be requested in addition to the $250,000.

This policy also impacts applications requesting a budget of $500,000 direct costsCosts 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. or more for any year. These applications require prior approvalWritten 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). from Institute/Center staff; however, the limit is exclusive of any consortium F&A costsNecessary 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.. It does not affect any specific FOA that includes a total cost limit.

This policy does not affect the SBIR and STTR programs since the statutory budget guidelines are based on total costs, not direct costsCosts 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.. It also does not affect any specific Funding Opportunity AnnouncementA publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts. that has a Total Cost limit.

2.3.7.2 Acceptance for Review of Unsolicited Applications Requesting $500,000 or More in Direct Costs

Any applicant requesting $500,000 or more in direct costsCosts 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. (excluding consortium F&A costsNecessary 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.) in any one budget period is required to contact the ICThe 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. PO, in writing or by telephone, as early as possible during development of the application but no later than 6 weeks before submission for prior approvalWritten 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 requirement applies to a single grant application, whether a new, renewal, revision, or resubmission application, under any NIH support mechanism; it also applies to a group of applications, such as those for clinical trial networks, meeting the $500,000 threshold in the aggregate even if no single application in the group requests that much.

This policy does not apply to applications submitted in response to RFAs or to other announcements that include specific budgetary limits. However, any such application must be responsive to budgetary limits specified or NIH will administratively withdraw the application and it will not be reviewed or considered for funding.

Applicants must seek agreement from ICThe 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. staff at least six weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costsCosts 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. for any year (excluding consortium F&A costsNecessary 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 staff is contacted less than six weeks before submission, there may be insufficient time to make a determination about assignment prior to the intended submission date. If the requested dollars are significantly greater than $500,000, then approval should be sought even earlier.

The PD/PI must include a cover letter with the application identifying the PO contacted and the ICThe 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. that has agreed to accept assignment of the application. CSR will accept such applications for review only if an ICThe 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. has agreed to accept the application for consideration and the applicant submits with its application a letter to that effect with the name of the authorizing program staff member and ICThe 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. affiliation (see The Peer Review Process). An application subject to this policy that does not include the required information in the cover letter will be administratively withdrawn and will not be reviewed or considered for funding.

2.3.7.3 Resubmission of Unfunded RFA Applications

This policy applies to all activity codes that might be solicited via an RFA and to instances where there is a change in activity code. Unless a particular FOA states that resubmissions from an RFA may be submitted, unfunded applications should be submitted as new applications if the grant applications fall into the following categories:

  1. Applications that were originally submitted in response to an RFA and now submitted as an investigator-initiated application.
  2. Applications that were originally submitted as investigator-initiated applications and subsequently submitted in response to an RFA.
  3. Applications that were originally submitted using one grant activity code and subsequently submitted using a different grant activity code (for example, an application that was originally an R01 and is now submitted as an R21).

The new application must be submitted on the scheduled due dates for new applications and follow all instructions that apply to new applications. Do not include an Introduction describing the changes and improvements made; do not mark text to indicate the changes; and do not explicitly address reviewers' comments. In these cases the reviewers will not be provided with the previous summary statement.

2.3.7.4 Submission of Resubmission Application

NIH will accept a new (A0) application following an unsuccessful resubmission (A1) application. The subsequent new application need not demonstrate substantial changes in scientific direction compared to previously reviewed submissions, and must not contain an introduction to respond to the critiques from the previous review. NIH's policy for accepting overlapping applications remains in effect: NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not review:

  1. a new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping resubmission (A1) application.
  2. a resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  3. an application that has substantial overlap with another application pending appeal of initial peer review (see Section 2.3.9.4 below)

NIH policy allows a thirty-seven month window for one resubmission (A1) following the submission of a new, renewal, or revision application (A0 application). The initial submission of a new, renewal or revision application constitutes the starting point for the thirty-seven month policy. After thirty-seven months, NIH views a submission as a new application, regardless of whether an unsuccessful resubmission (A1) was submitted during the thirty-seven month time period.

Submission to a different FOA under review at the same time is not sufficient to make an application new. (There are exceptions for applications following an RFA or changing activity code. See Resubmission of Unfunded RFA Applications above). The new application must be submitted on the scheduled due dates for new applications (see http://grants.nih.gov/grants/funding/submissionschedule.htm). It must not include an Introduction describing the changes and improvements made; and the text must not be marked to indicate the changes.

2.3.7.5 New Investigators and Early Stage Investigators

The NIH is committed to identifying and attracting new biomedical researchers and will continue to explore novel ways to encourage early transition to independence. NIH has implemented a number of policies specific to New Investigators, and in particular the category of New Investigator called Early Stage InvestigatorAn individual who is classified as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI). See definition of New Investigator..

New Investigator. In general, a PD/PI is considered a New Investigator if he/she has not previously competed successfully as PD/PI for a substantial independent research award. For example, a PD/PI who has previously received a competing NIH R01 research grant is no longer considered a New Investigator. See definitions section for additional information and references.

Early Stage InvestigatorAn individual who is classified as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI). See definition of New Investigator. (ESI). An ESI is a New Investigator who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). Extensions of the end of ESI eligibility date may be requested following the procedures documented on the New Investigator Web site.

The NIH intends to support New Investigators at success rates comparable to those for established investigators submitting new applications. ESIs should comprise a majority of the New Investigators supported. Where possible, New Investigator applications will be clustered during review. The applications will be given special consideration during peer review and at the time of funding. Peer reviewers will be instructed to focus more on the proposed approach than on the track record, and to expect less preliminary data than would be provided by an established investigator.

NIH New Investigator policies are limited to applications for traditional research project grant (R01) support. Accordingly, the NIH strongly encourages New Investigators, particularly ESIs, to apply for R01 grants when seeking first-time NIH funding. To determine New Investigator and Early Stage InvestigatorAn individual who is classified as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI). See definition of New Investigator. status, NIH relies on the data entered by the individual in their eRA Commons Profile, therefore it is important that PD/PIs verify the accuracy of their personal profiles. Particularly key for ESIs are the terminal research degree and end date of residency data fields. ESI status and end of eligibility date also appear in the Commons profile for the individual.

2.3.7.6 Program Director/Principal Investigator, Individual Fellowship and Sponsor Assurance

The applicant organization is required to secure and retain a unique signature and dated assurance from the PD/PI for each submitted application, prior to submitting an application to the NIH. This assurance must be available to the NIH or other authorized DHHS or Federal officials upon request. Such an assurance must include at least the following certifications: 1) that the information submitted within the application is true, complete and accurate to the best of the PI's knowledge; 2) that any false, fictitious, or fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalties; and 3) that the PI agrees to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application. If multiple PIs are proposed in an application, this assurance must be retained for all named PIs.

For individual Fellowship applications, this assurance requirement applies to the individual fellow and the sponsor. Such an assurance must include at least the follow certifications: (1) that the information submitted within the application is true, complete and accurate to the best of the Fellow's and Sponsor's knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the Fellow and Sponsor to criminal, civil, or administrative penalties; (3) that the Sponsor will provide appropriate training, adequate facilities, and supervision if a grant is awarded as a result of the application; (4) that the Fellow has read the Ruth L. Kirschstein National Research Service Award Payback and will abide by the Assurance if an award is made; and (5) that the award will not support residency training. NIH will not accept forms or other documentation bearing generic departmental signatures or their electronic equivalent (e.g., Department of Sponsored Research). All forms and documentation submitted to the NIH must reflect the name of the individual, electronic or otherwise, with the appropriate institutional authority to submit such information.

2.3.7.7 Post-Submission Grant Application Materials

Post-submission of application materials is not required. Adding materials to reviewer workload may be counterproductive, so applicants should carefully consider the need to send post-submission materials. For materials that are submitted after the initial grant application submission but prior to initial peer review, NIH will only accept such materials resulting from unforeseen administrative issues. This policy does not modify the Just-in-TimeNIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review when the application is under consideration for funding. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. requirements or any other requests for additional information after the initial peer review.

For all research and research-related applications, individual fellowship, and individual career development awards, acceptable materials include:

All post-submission materials must conform to NIH policy on font size, margins, and paper size as referenced in the applicable application instructions. Any material using established forms/format pages (e.g. budget pages, biographical sketches) must follow standards for those pages. If post-submission material is not on a required form/format page, each explanation or letter is limited to one page. If the application has subprojects or cores, each subproject or core is allowed explanations or letters, but each explanation or letter is limited to one page. See Non-traditional Application Materials below for further information on video.

Unacceptable post-submission materials include:

  • Updated Specific Aims or Research Strategy pages
  • Late-breaking research findings
  • New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Exceptions to this policy include:

  • Applications submitted in response to an RFA that has only one due date or the last due date when multiple due dates are available. Updated Specific Aims or Research Strategy pages, late-breaking research findings and new letters of support or collaboration will be allowed. If additional material is not required on a form/format page, post-submission materials for these applications are dependent on the number of pages of the Research Strategy section:
    • When the Research Strategy is fewer than 12 pages, additional materials are limited to one printed page.
    • When the Research Strategy is limited to 12 pages, additional materials are limited to two printed pages.
    • When the Research Strategy is greater than 12 pages, additional materials are limited to three printed pages.
    • When the application has subprojects or cores, additional materials follow the page limit of the Research Strategy of each subproject or core as indicated above.
  • Certain FOAs may allow specific other types of post-submission materials to facilitate the goals of the program. Such stipulations will be explained in the FOA.

For institutional training and training-related applications, including institutional Career Development Awards, up to three pages of post-submission materials will be allowed to present new information or data that was not available at the time of the application submission. Acceptable material includes:

  • Updated information and data on the applicant pool, admissions, enrollment, appointments and/or achievements
  • Updated faculty research support
  • For training-related programs (e.g., R25) acceptable post-submission materials will be detailed in the FOA

For Kirschstein-NRSA Fellowship and non-NRSA International Fellowship applications, update to the Sponsor(s)' funding information in the originally submitted application is allowed as post-submission material.

Non-traditional Application Materials

NIH will accept only videos as non-traditional application materials. No devices or other media will be accepted unless specified in the Funding Opportunity AnnouncementA publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts. (FOA). However, videos may include demonstrations of devices and other items as listed below. These guidelines may be superseded by instructions in specific FOAs.

The only acceptable content for videos is demonstrations of devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change.

Application requirements. The application must be structured at the time of submission to indicate that a video will be submitted subsequently. The cover letter submitted with the application must include information about the intent to submit a video; if this is not done, a video will not be accepted. Key images/"stills" and a brief description of each video must be included within the page limits of the research strategy. Sufficient descriptive information must be provided within the research strategy to understand the information presented in the video, as not all reviewers may be able to access the video, depending on technological constraints.

When human subjects or personally identifiable information is represented in a video, the applicant organization is responsible for ensuring that human subjects have been consented and protected appropriately. Submission through the Authorized Organizational Representative (AOR) certifies acceptance of this responsibility.

Video formats. Multiple videos may be submitted per application but their aggregate length must not exceed 2 minutes for single-project applications and 5 minutes for multi-component applications.

Post-submission videos must be embedded in .pdf files with a maximum file size of 25 MB. This material can be submitted on CD/DVD or via e-mail and it will be uploaded to the grant folder by the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h).. Currently popular, cross-platform, video formats include mp4, mov, avi, flv, and wmv.

Closed captioning is not required when narration is present. However, captioning is recommended as an optional component of the video to assist reviewers evaluating the application.

Limitations. Video files containing unacceptable content or exceeding the time or size limits will not be accepted. Applications submitted with hyperlinks to videos or with videos embedded in the research strategy will be considered in violation of page limits and the application will be withdrawn before review.

Note: Due to technological constraints, the NIH cannot guarantee that reviewers will be able to view videos.

Video submission. If the submission requirements have been met (see above), videos will be accepted by the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). managing the review. After the assignment of the application to a review group is visible in the eRA Commons, the applicant should contact the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). for that review group to discuss logistics for submission of any videos.

As with all other post-submission materials, videos must be received by the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). one month (30 calendar days) prior to the peer review meeting. Videos will not be accepted if fewer than 30 calendar days remain before the peer review meeting.

Concurrence from the Authorized Organization RepresentativeThe 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. (AOR) of the applicant organization is required. Although the video may originate from the Program Director/Principal InvestigatorThe individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. (PD/PI), Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must send the materials directly to the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h)., or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h).. A communication from the PD/PI only or with a "cc" to the AOR will not be accepted.

The opportunity to submit additional materials should not be a means of circumventing submission deadlines, page limitations, or content requirements and should not substantially enhance, alter or add to the originally submitted application.

After the initial peer review phase is completed, the Chief GMO of the ICThe 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. is the NIH official responsible for accepting additional materials. Most of the material submitted after peer review can be submitted as part of the Just-in-TimeNIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review when the application is under consideration for funding. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. process.

Effective for applications submitted for the January 25, 2017 due date and thereafter, NIH is consolidating the policy concerning post-submission materials. The text above in subsection 2.3.7.7 is rescinded and replaced by the following:

Post-submission of application materials is not required. Adding materials to reviewer workload may be counterproductive, so applicants should carefully consider the need to send post-submission materials. For materials that are submitted after the initial grant application submission but prior to initial peer review, NIH will only accept such materials resulting from unforeseen administrative issues. This policy does not modify the Just-in-TimeNIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review when the application is under consideration for funding. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. requirements or any other requests for additional information after the initial peer review.

Allowable Post-Submission Materials for All Applications

For all research and research-related applications, individual fellowship, and individual career development awards, acceptable materials include:

Copies of articles, links to articles, or any other materials related to an article accepted for publication will not be accepted as post-submission materials, unless specified in the Funding Opportunity AnnouncementA publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts. (FOA) for which the application was submitted or a special Guide Notice.

Additional Materials for Certain Applications

Institutional Training and Training-related Grants (e.g., T32, T34, T35, T90, TU2, T15, D43, K12, KM1, UR2): in addition to the materials for All Applications above, news-since the training grant application was submitted-of:

  • a trainee's or former trainee's graduation, employment, promotion, funding, or publications;
  • a faculty member's promotion, funding, or publications; and
  • the addition or removal of any faculty member who will be involved in the training program (mentors or senior/key persons).

Individual Fellowship (F-Series) and Individual Career Development Award (K-series) Applications: in addition to the materials for All Applications listed above:

  • New information on the Sponsor/Mentor funding, limited to the project title, funding source (e.g., NIH grant number), a brief description of specific aims, and relevance to the fellowship or career development application under review.
  • News of change in Mentor(s) or other Senior/Key Persons specified in the original application.

Applications submitted to Requests for Applications (RFAs): the same post-submission materials as other applications (see "All Applications" above), for all due dates in the RFA.

Conference Grant Applications (R13, U13): a one-page explanation of all speakers who accepted invitations to participate in the proposed conference after the application was submitted, plus a one-page explanation of all speakers who declined such invitations after the application was submitted. Alternatively the PD/PI may consider submitting a one-page explanation for each plenary slot on the agenda.

Any other types of post-submission materials are not likely to be accepted.

Requirements for Submitting Post-Submission Materials

All post-submission materials must conform to NIH policies on font size, margins, and paper size as referenced in the applicable application instructions.

  • Any specified formats (e.g., budgets, biographical sketches) and page limits referenced in the applicable application instructions apply.
  • If post-submission material is not required on a specific format page and does not have a specified page limit, each explanation or letter is limited to one page.
  • If the application has multiple components (subprojects or cores), each subproject or core is allowed explanations or letters, but each explanation or letter is limited to one page.

Post-submission materials must be received by the NIH Scientific Review Officer (SRO)The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). no later than 30 calendar days prior to the peer review meeting. Post-submission materials will not be accepted if fewer than 30 calendar days remain before the peer review meeting, unless specifically stated otherwise in the FOA for which the application was submitted or in a special Guide Notice.

Concurrence from the Authorized Organization RepresentativeThe 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. (AOR) of the applicant organization is required. Although the post-submission materials may originate from the PD/PI, Contact PD/PI, or organizational officials, the AOR must send the materials directly to the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h).. A communication from the PD/PI only or with a "cc" to the AOR will not be accepted.

Post-submission materials can only be submitted as a PDF attachment. The SROScientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). is responsible for uploading acceptable materials into the official electronic grant file maintained in the eRA Commons. The PD/PI can check his/her application via the Commons to see these materials in the section titled "Additions for Review". This procedure provides the information to reviewers in a secure manner.

2.3.7.8 DUNS Number and SAM Registration Requirements

All applicant organizations must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual PD/PIs do not need to register for a DUNS.

Additionally, all applicant organizations must register in the System for Award Management (SAM) and maintain the registration with current information at all times during which it has an application under consideration for funding by NIH and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/portal/public/SAM/.

If an award is granted, the recipient organization must notify potential subrecipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the recipient organization.

2.3.7.9 Graduate Student Compensation

The maximum amount NIH will award for the support of a graduate student on a research grant or a cooperative agreement is tied to the National Research Service Award (NRSA) zero-level stipendA 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. in effect at the time the grant award is issued on the Federal award date. The schedule for NRSA stipendsA 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. can be found at http://researchtraining.nih.gov. Consistent with cost principlesThe 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. for Institutions of Higher Education (IHEs) described in 45 CFR 75.431(j) and 75.466, the compensation of graduate students supported by research grants must be reasonable. These operating principles associated with the compensation of students performing necessary work on NIH funded research projects are described in detail in the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy. The amount provided for compensation includes salary or wages, fringe benefits, and tuition remission.

These guidelines apply to graduate students at the recipient institution who are supported by NIH research grants and cooperative agreements and not to individuals supported by NRSA training grants and fellowships. NIH has separate appropriations to support research training under the NRSA authorization at Section 487 of the Public Health Service Act.

The stipendsA 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. provided to recipients of NRSA support offset the cost-of-living during the period of training and are not considered equivalent to salaries or other forms of compensation provided to individuals supported on research grants. Nevertheless, the entry-level postdoctoral NRSA stipendA 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. provides a useful benchmark for an award amount that approximates a reasonable rate of compensation for graduate students. Expected future increases in NRSA stipendsA 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., to adjust for inflation, should permit annual increases in the maximum award for such individuals.

For all new and competing grant and cooperative agreement awards, the NIH will provide reasonable amounts for graduate compensation, consistent with the requested budget for the position(s) and up to the currently effective NRSA zero postdoctoral stipendA 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. level. NIH staff will review the compensation requested for graduate students on competing and cooperative agreement applications for which a detailed budget is submitted. NIH will neither request nor accept budgets for those applications using a modular budget format solely for the purpose of reviewing graduate student compensation. However, applicants should use this policy when estimating the number of modules.

When submitting detailed budgets that request support for a graduate student, recipients are reminded to request actual institutional-based compensation and to provide information justifying the requested compensation level. If this information is not provided, NIH staff will obtain this information from the institution's business office for any request that appears excessive.

NIH Institutes and Centers will review the requested compensation level and, if considered reasonable, will award the actual amount requested, up to a maximum equal to the NRSA zero level postdoctoral stipendA 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.. Revised budgets submitted solely to adjust requested levels for graduate students will not be accepted.

Institutions may continue to rebudget funds to charge more than the awarded amount provided that OMB cost principlesThe 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. requiring reasonable compensation are observed. In general, graduate student compensation will not be considered reasonable if in excess of the amount paid to a first-year postdoctoral scientist at the same institution performing comparable work.

2.3.7.10 NIH Genomic Data Sharing

NIH Genomic Data Sharing (GDS) Policy expects that applicants preparing grant applications state in the cover letter when the studies proposed will generate large-scale human and/or non-human genomic data. Applications proposing such research are expected to include a genomic data sharing plan. Guidance on developing data sharing plans may be found here: http://gds.nih.gov/pdf/NIH_guidance_developing_GDS_plans.pdf.

Applicants who wish to use controlled-access human genomic data from NIH-designated data repositories as a secondary user, to achieve the specific aim(s) of the research proposed in the Research Plan of the application, should briefly address their plans for requesting access to the data, and state their intention to abide by the NIH Genomic Data User Code of Conduct. NIH acknowledges that data sharing is not always possible. Exceptions to the data sharing expectation may be requested in cases where the criteria in the Institutional Certification cannot be met.