NIH Grants Policy Statement
Revised October 2017. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2017.
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2.3 Application Information and Processes

This section provides an overview of NIH's grant support mechanisms, types of entities eligible to receive grants, types of applications, types of funding opportunities, legal implications of applications, policies affecting application preparation and submission, application forms, application receipt information and deadlines, fraud, waste and abuse of NIH grant funds, and availability and confidentiality of application information.

2.3.1 Support Mechanisms

NIH ICs award grants under multiple programs and subprogram initiatives and use a variety of support mechanisms. NIH grants may be distinguished by purpose, type of recipient, amount, or other characteristics. One method NIH uses to differentiate the various support mechanisms is activity coding that indicates the category and specific form of support (e.g., R01, F32, P01, R43). The applicability of requirements may vary for different activity codes. Some of the distinctions also are significant for purposes of applying Part II. NIH ICs may vary in the way they use specific activity codes; not all ICs accept applications for all types of grant programs and may apply specialized eligibility criteria. A comprehensive list of activity codes is available at http://grants.nih.gov/grants/funding/ac_search_results.htm.

2.3.2 Eligibility

In general, NIH grants may be awarded to organizations that are domestic or foreign, public or private, or non-profit or for-profit. Eligible organizations include governments, including Federal institutions, institutions of higher education, other non-profit organizations, hospitals, and, in rare occasions, individuals (see Completing the Pre-Award Process-Determining Applicant Organization Eligibility). Any special criteria for applicant eligibility or requirements concerning the qualifications of the PD/PI or other staff or participants will be specified in the FOA, program guidelines, or other publicly available documents. Part IIB includes information on fellow and trainee eligibility.

2.3.3 Types of Award Instruments

NIH uses several different extramural award instruments in support of its mission. NIH grants and cooperative agreements are financial assistance instruments. Under a cooperative agreement, NIH expects to be substantially involved in carrying out the project. Grants are used both for investigator-initiated research and for more targeted research. Cooperative agreements generally do not result from investigator-initiated applications. The NIHGPS pertains to grants and cooperative agreements; however, NIH may apply terms and conditions that differ from those in the NIHGPS consistent with the nature of its involvement under cooperative agreements.

2.3.4 Types of Applications

In the NIH grants process, five types of applications are used most frequently. The first four application types described below are considered "competing" because, through the peer review process, the application must compete for available funding with other applications.

In addition to the list above, NIH periodically uses a pre-application (also known as a "white paper" or "précis") to facilitate certain approaches or economies, such as reducing burden on the applicant community, for a funding opportunity. Pre-applications are generally used in combination with a competing application in a 2-phase process. Pre-applications do not result in an award; the end result is the opportunity to submit to the subsequent phase of a particular program. Successful applicants to the pre-application phase are notified of the opportunity to submit to the subsequent phase. In addition to the pre-application, NIH may use an application process for prospective applicants to request access to an NIH research resource. This process also does not result in an award; the end result is permission to access a resource. NIH uses the numbers shown in parentheses as prefixes to distinguish the application types and any resulting awards (e.g., 5R0198765-02 is a non-competing continuation progress report).

2.3.5 Types of Funding Opportunity Announcements (FOAs)

The majority of applications submitted to NIH under the categories of research and research training (including fellowships) are investigator-initiated. NIH accepts applications on the application due dates noted on the submission schedule. NIH generally reviews applications in three review cycles per year; however any variations in schedule will be noted in the FOA. Some ICs review applications for Institutional National Research Service Awards (T32) only once a year; such information is generally found in a particular FOA. The schedules for submission, review, and award of investigator-initiated applications are available at http://grants.nih.gov/grants/funding/submissionschedule.htm.

Funding Opportunity Announcement (FOA). A FOA is a publicly available document in which a Federal agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. FOAs may be program announcements, requests for applications, notices of funding availability, solicitations, or other identifiers depending upon the agency and type of program. All applications must be submitted in response to a FOA regardless if the submission is electronically or on paper. FOAs include information to allow prospective applicants to determine whether to apply.

NIH FOAs primarily fall into the categories of Program Announcements, Request for Applications and Parent Announcements. While individual announcements will continue to carry an announcement number reference to PA or RFA, all announcements are FOAs. This general term is used to reference any type of funding announcement. NIH uses the PA and RFA references in the actual announcement number to distinguish between the various types of announcements.

PAs may be used for any support mechanism other than construction awards. Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated. PAs also are used to annually solicit applications for the SBIR and STTR programs. Those applications must be received by the dates specified in the PA.

Effective for applications with receipt dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a FOA specifically designed for clinical trials. NIH will no longer accept clinical trial applications through "parent" FOAs or through other FOAs that are not specifically designed to accept clinical trials. This policy will apply to all applications involving one or more clinical trials, including applications that involve a combination of studies that are clinical trials as well as studies that are not. These latter "hybrid" FOAs include applications that will involve a combination of trial and non-trial aims. These and other types of trial applications will also be submitted to clinical trial-specific FOAs if the combination of studies involve a NIH defined clinical trial.

All NIH FOAs are published in the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/index.html) and on Grants.gov under Find Grant Opportunities (https://grants.nih.gov/funding/index.htm). NIH may develop areas of high priority or special research interest and use a special announcement to stimulate submission of applications in those areas. These announcements are also published as FOAs in the NIH Guide for Grants and Contracts.

2.3.6 Legal Implications of Applications

An applicant must be an eligible entity and must submit a complete application in accordance with established receipt (deadline) dates in order to be considered for support. The signature of an AOR on the application certifies that the organization will comply with all applicable assurances and certifications referenced in the application. The applicant organization is responsible for verifying conformity with the most current guidelines for all administrative, fiscal, and scientific information in the application, including the F&A cost (indirect cost) rate. The AOR's signature further certifies that the applicant organization has the ability to provide appropriate administrative and scientific oversight of the project and agrees to be fully accountable for the appropriate use of any funds awarded and for the performance of the grant-supported project or activities resulting from the application. 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.

Applicants for and recipients of NIH grant funds, whether such funds are received through a grant, indirectly under a contract or consortium agreement, or by a fiscal agent acting on another organization's behalf, or as student assistance under a training grant, are responsible for and must adhere to all applicable Federal statutes, regulations, and policies, including income tax regulations. Questions concerning the applicability of income tax regulations to grant funds should be directed to the IRS. The applicant also is expected to be in compliance with applicable State and local laws and ordinances.

Applicants may be required to provide proof of organizational eligibility (such as proof of non-profit status), trainee or fellow eligibility and citizenship, or other eligibility information. Applications also must demonstrate compliance (or intent to comply), through certification or other means, with a number of public policy requirements. The more significant of the public policy requirements for the purpose of peer review are those concerning research involving human subjects; inclusion of both genders, members of minority groups, and children in clinical research; and research involving live vertebrate animals. Part II details public policy requirements and cost and administrative policies.

There are times when an institution desires to use a Foundation or other similar organization to provide administrative services for NIH grants. These situations are often complex and each situation is unique when determining which organization is the appropriate applicant institution. Foundations, particularly those associated with institutions already recognized as NIH recipient organizations, should contact DGP, OPERA before attempting to separately register as an applicant organization.

Similarly, when new consortiums are formed where the consortium members are already separately recognized as NIH recipient organizations, DGP, OPERA should be contacted before attempting to separately register as a new applicant organization.

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 principles 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 cost limit, NIH policy excludes consortium/contractual F&A when determining if an applicant is in compliance with the direct cost 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 costs, regardless of budget amount or budget format (e.g., modular and non-modular). While consortium F&A costs may be requested and awarded, applicants should not consider these costs when determining if a budget exceeds a direct cost 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 costs per year. Consortium/contractual F&A costs are not factored into this direct cost limit; however, they may be requested in addition to the $250,000.

This policy also impacts applications requesting a budget of $500,000 direct costs or more for any year. These applications require prior approval from Institute/Center staff; however, the limit is exclusive of any consortium F&A costs. 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 costs. It also does not affect any specific Funding Opportunity Announcement 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 costs (excluding consortium F&A costs) in any one budget period is required to contact the IC 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 approval. 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 IC staff at least six weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs). 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 IC that has agreed to accept assignment of the application. CSR will accept such applications for review only if an IC 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 IC 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 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 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 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-Time 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:

Exceptions to this policy include:

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:

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 Announcement (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 SRO. 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 SRO managing the review. After the assignment of the application to a review group is visible in the eRA Commons, the applicant should contact the SRO 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 SRO 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 Representative (AOR) of the applicant organization is required. Although the video may originate from the Program Director/Principal Investigator (PD/PI), Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must send the materials directly to the SRO, or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SRO. 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 IC 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-Time 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-Time 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 Announcement (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:

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

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.

Post-submission materials must be received by the NIH Scientific Review Officer (SRO) 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 Representative (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 SRO or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SRO. 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 SRO 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 stipend in effect at the time the grant award is issued on the Federal award date. The schedule for NRSA stipends can be found at http://researchtraining.nih.gov. Consistent with cost principles 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 stipends 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 stipend provides a useful benchmark for an award amount that approximates a reasonable rate of compensation for graduate students. Expected future increases in NRSA stipends, 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 stipend 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 stipend. 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 principles 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.

2.3.8 Application Forms

Exhibit 3 lists the required application forms for competing applications, which vary by support mechanism. These forms and associated instructions are available on the OER forms page (http://grants.nih.gov/grants/forms.htm).

Exhibit 3. Required Forms for Competing Applications

Application Title Form Number Use
SF424 (R&R) Application Guide for NIH and Other PHS Agencies SF424 (R&R) The SF424 (R&R) form set, combined with PHS 398 components, is used for electronic submission.
SF424 (R&R) Individual Fellowship Application Guide for NIH and AHRQ

SF424 (R&R)

and

PHS 416-1

The SF424 (R&R) form set, combined with a PHS Fellowship Supplemental form component, is used for electronic submission of individual fellowship applications. The Fellowship Supplemental form component is from the PHS 416-1.
Application for a Public Health Service Grant PHS 398 Form PHS 398 is used for paper submission for those programs that have not yet transitioned to electronic submission.

The majority of NIH competing applications now require electronic application submission. The FOA will identify whether the application requires electronic or paper submission. Paper submissions require use of the PHS 398 application form. An electronic submission requires the use of a unique set of application forms that combine SF424 (R&R) forms with agency-specific forms (e.g., 398 component forms, Fellowship supplemental component form). For electronically submitted applications, the applicable forms package and instructions is attached to a specific FOA. Questions about application forms and instructions may be directed to GrantsInfo, OER, NIH; see Part III for contact information.

2.3.9 Application Receipt Information and Deadlines

Applicants should carefully read instructions in the FOA and the application guide to determine submission requirements. The FOA will either provide unique application deadlines or refer to NIH's standard receipt dates.

NIH expects all applications (paper and electronic) to be submitted on time. Permission is not granted in advance for submission of a late application. Late applications are accepted only in extenuating circumstances. If an application is submitted late, a cover letter explaining the reasons for the delay must be included with the signed, completed application. Late applications are evaluated on an individual basis considering the reasons provided. Only DRR, CSR has the authority to accept a late application; however, contacting DRR in advance will not influence the acceptance of a late application. The NIH policy on late applications is stated in the applicable application instructions. Also see 2.3.9.2 - Electronically Submitted Applications, below.

2.3.9.1 Paper Applications

Paper application submission dates fall under two different categories: 1) Standard Postmark/Submission Dates (also known as "send by" dates) and 2) Special Receipt Dates (also known as "arrive by" dates) which are specified in RFAs and PAs.

Applications submitted for the standard submission dates are considered on time if they are sent on or before the appropriate date listed and a proof of mailing is provided. The critical determination is when the application is sent, not when it arrives at NIH. Proof of timely mailing consists of one of the following: a legibly dated U.S. Postal Service postmark, or a dated receipt from a commercial carrier or the USPS. Private metered postmarks are not acceptable.

All paper applications must be submitted via either courier delivery or the USPS. The number of copies specified in the application instructions or announcement must be submitted to the central NIH receipt point for CSR noted in Part III.

Preaddressed mailing address labels are available on the applicable forms page on the OER Web site.

Do not hand deliver your application to CSR. Applications delivered by individuals will not be accepted.

If the submission date falls on a weekend or a Federal holiday, the date for receipt/mailing is extended to the next business day. The application will be on time if it is sent on or before the following business day. The ten Federal holidays are: New Years Day, Birthday of Martin Luther King, Jr., Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

A paper application submitted in response to an FOA with a unique receipt date (if one is specified in the FOA) must be received at NIH by the specified date. However, an application received after the deadline may be accepted if it carries a legible proof-of-mailing date assigned by the carrier not later than 1 week prior to the deadline date. This applies only to FOAs with specific, published receipt dates, i.e., dates other than the standard ones used for investigator-initiated applications. For FOAs using the standard submission dates, the policies described above for "send by" dates apply.

2.3.9.2 Electronically Submitted Applications

For applications submitted electronically for the Standard Submission Dates, on time submission means the electronic grant application must be successfully submitted to Grants.gov on or before 5:00 p.m. local time (of the applicant institution/organization) on the appropriate date listed.

Applications submitted to FOAs with a single submission date are considered on time if they are submitted to Grants.gov on or before 5:00 p.m. local time (of the applicant institution/organization) on the appropriate date listed. Applications submitted for Special Receipt Dates are considered on time if they are submitted to Grants.gov on or before 5 p.m. local time on the Grants.gov Closing Date. RFAs and PARs with special receipt dates always must be received by Grants.gov on the dates designated in the announcement.

If a submission date falls on a weekend, it will be extended to the following Monday; any time the date falls on a Federal holiday (see list of Federal holidays in Paper Applications above), the submission date will be extended to the following business day. The application will be on time if it is submitted on or before the following business day.

There is a two week window of consideration after the application due date, during which time NIH might consider accepting a late application (see details below). When the application due date falls on a weekend or Federal holiday, and is extended to the next business day, the window of consideration for late submission of applications will be calculated from that business day. Acceptance of late applications will be made on a case-by-case basis, dependent upon the explanation provided in a cover letter submitted with the application.

NIH will not consider accepting late applications under the following circumstances:

Funding Opportunity Announcement Type

 

PA*

PAR

RFA

 

2 week

2 week

2 week

 

 

 

none

Application Due Dates Field states: "No late applications will be accepted for this Funding Opportunity Announcement"

*Includes PAS: Program Announcement with Set-Aside Funds

NIH does not expect to accept any applications received beyond the window of consideration or for RFAs that specify no late applications will be accepted.

Please be aware that any reasons for late submission must be in relation to the individual(s) with the PD/PI role on the application. For multiple PD/PI (MPI) applications, the reasons may apply to any or all of the PD/PIs. This accommodation does not apply to co-Investigators, project leaders in a multi-component application, or other Key Persons listed in an application (unless they also have MPI status).

The windows of time for consideration of late applications have been carefully chosen so that the late applications can be processed with the cohort of on-time applications. Note that the late window always ends in a receipt (not submission) date.

Late applications are evaluated on an individual basis considering the reasons provided. Contacting the Division of Receipt and Referral, Center for Scientific Review (CSR), NIH in advance will not influence the acceptance of a late application. Additional information on submission of electronic applications can be found in the applicable SF424 (R&R) Application Guide.

2.3.9.3 Modified Submission Policy for Appointed Members of NIH Review and Advisory Group and Reviewers with Recent Substantial Service

An alternative submission policy is available for certain applications submitted listing as PD/PI individuals serving as appointed members of NIH chartered standing study sections, NIH Boards of Scientific Counselors, NIH Advisory Boards or Councils, NIH Program Advisory Committees, and/or peer reviewers who have served as regular or temporary members six times in 18 months. This policy applies to R01, R21, and R34 applications that would normally be received on standard application submission dates (not special receipt dates); and allows for applications to be submitted as soon as they are fully developed. The applications will be reviewed no later than 120 days after receipt. Applications using the multiple PD/PI model, are eligible if one or more of the PD/PIs are eligible for continuous submission. Continuous submission does not apply to applications for which the eligible members have roles other than PD/PI, including eligible members as sponsors for fellowships and mentors for career award applications.

See frequently asked questions at http://grants.nih.gov/grants/peer/faq_continuous_submission.doc.

2.3.9.4 Similar, Essentially Identical, or Identical Applications

Simultaneous submissions of identical applications to one or more components of the PHS are not allowed, and the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization for the same receipt date. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Likewise, identical or essentially identical grant applications submitted by different applicant organizations will not be accepted for the same receipt date. Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may not be reviewed.

Essentially identical applications will not be reviewed except for: 1) individuals submitting an application for an Independent Scientist Award (K02) proposing essentially identical research in an application for an individual research project; 2) individuals submitting an individual research project identical to a subproject that is part of a program project or center grant application; 3) submissions of applications previously submitted to an RFA that were not paid or resubmissions of investigator-initiated applications originally submitted to an RFA (see Grants Policy Statement section 2.3.7.3); and 4) resubmissions of applications with a changed grant activity code.

2.3.9.5 Application Non-conformity

Applicants are reminded that non-conformity with application requirements can have serious consequences. NIH may withdraw any application identified during the receipt, referral and review process that does not conform with the instructions in the SF424 (R&R) Application Guide, the Funding Opportunity Announcement, and relevant NIH Guide Notices.

Some examples of how this policy is applied to NIH applications include but are not limited to:

It is important to remember that these are just examples, and that all requirements specified in the SF424 (R&R) Application Guide, the Funding Opportunity Announcement, and relevant NIH Guide Notices are to be followed. Questions about application requirements can be directed to NIH "Grants Info" or the Division of Receipt and Referral.

If an application is withdrawn because it does not conform to the application preparation and submission instructions, a letter will be placed in the eRA Commons Status page for that application.

2.3.10 Fraud, Waste and Abuse of NIH Grant Funds

Any individual who becomes aware of the existence (or apparent existence) of fraud, waste, or abuse related to NIH grants or grant funds should consider contacting:

In addition, allegations of criminal offenses should be reported to the Department of Health and Human Services, OIG Hotline.

The OIG has authority within HHS to conduct criminal investigations. The HHS OIG maintains a post office box and a toll-free hotline for receiving information from individuals concerning fraud, waste, or abuse under HHS grants and cooperative agreements. The identity of the caller is kept confidential, and callers are not required to give their names. The address and telephone number of the OIG and the OIG hotline are included in Part III.

Further allegations of non-criminal misuse of grant funds, and recipient conflict of interest should be reported to the NIH OMA.

OMA provides a centralized management survey and review capability to promote program integrity, conducts appraisals of alleged incidents of waste, fraud, and abuse and has lead responsibility for cases received through the Office of Inspector General (OIG) Hotline that are referred to NIH for action. OMA has no authority to undertake criminal investigations. OMA refers all allegations of criminal offenses to the OIG for investigation. The address and telephone number for the OMA, DPI are included in Part III.

Examples of fraud, waste, and abuse that should be reported include, but are not limited to, embezzlement, misuse, or misappropriation of grant funds or property, and false statements, whether by organizations or individuals. Other examples include theft of grant funds for personal use; using funds for non-grant-related purposes; theft of federally owned property or property acquired or leased under a grant; charging the Federal government for the services of "ghost" individuals; charging inflated building rental fees for a building owned by the recipient; submitting false financial reports; and submitting false financial data in bids submitted to the recipient (for eventual payment under the grant).

The Federal government may pursue administrative, civil, or criminal action under a variety of statutes relating to fraud and making false statement or claims. Part II includes administrative and other remedies the Federal government may use if a recipient deliberately withholds information or submits fraudulent information or does not comply with applicable requirements. Even if a grant is not awarded, the applicant may be subject to penalties if the information contained in or submitted as part of an application, including its certifications and assurances, is found to be false, fictitious, or fraudulent.

The Program Fraud Civil Remedies Act of 1986, 31 U.S.C. 3801 et seq., provides for the administrative imposition by HHS of civil penalties and assessments against any person who knowingly makes false, fictitious, or fraudulent claims to the Federal government for money, including money representing grants, loans, or benefits. A civil penalty of not more than $5,500 may be assessed for each such claim. If a grant is awarded and payment is made on a false or fraudulent claim, an assessment of not more than twice the amount of the claim, up to $150,000, may be made in lieu of damages. Regulations established by HHS at 45 CFR 79 specify the review process for imposing civil penalties and assessments, including hearing and appeal rights.

The Criminal False Claims Act, 18 U.S.C. 287, and 18 U.S.C. 1001, provides for criminal prosecution of a person who knowingly makes or presents any false, fictitious, or fraudulent statements or representations or claims against the United States. Violations of these statutes carry a maximum sentence of 5 and 8 years imprisonment, respectively.

The Civil False Claims Act, 31 U.S.C. 3729(a), provides for imposition of penalties and damages by the United States, through civil litigation, against any person who knowingly makes a false or fraudulent claim for payment, makes or uses a false record or false statement to get a false claim paid or approved, or conspires to defraud the Federal government to get a false claim paid. A "claim" includes any request or demand for money or property made to the United States or to a contractor, recipient, or other recipient, if the Federal government provides or will reimburse any portion of the funds claimed. Civil penalties of $5,500 to $11,000 may be imposed for each false claim, plus damages of up to three times the amount of the damages the government sustains because of the violation, and the costs of any civil action brought to recover such penalties and damages.

NIH also may administratively recover misspent grant funds pursuant to the authorities contained in 45 CFR 75.

2.3.11 Availability and Confidentiality of Information

2.3.11.1 Availability of Information

Except for certain types of information that may be considered proprietary or private information that cannot be released, most grant-related information submitted to NIH by the applicant or recipient in the application or in the post-award phase is considered public information and, once an award is made, is subject to possible release to individuals or organizations outside NIH. The statutes and policies that require this information to be made public are intended to foster an open system of government and accountability for governmental programs and expenditures and, in the case of research, to provide information about federally funded activities.

NIH routinely places information about awarded grants, including project title, the name of the PD/PI, and the project description, on the RePORT Web site (see http://report.nih.gov). For funded research grant applications, NIH also sends the project description provided by an applicant to the DoC's NTIS. NTIS disseminates scientific information for classification and program analysis. The public may obtain the project descriptions from RePORT or request them from NTIS. Other information may be released case by case as described in this subsection.

Several policies require acknowledgment of support and a disclaimer for publications, inventions, and other research products, as provided in Administrative Requirements-Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources and elsewhere in the NIHGPS.

2.3.11.2 Confidentiality of Information

Applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, if the application contains information that the applicant organization considers to be trade secrets, information that is commercial or financial, or information that is privileged or confidential, the pages containing that information should be identified as specified in the application instructions.

When such information is included in the application, it is furnished to the Federal government in confidence, with the understanding that the information will be used or disclosed only for evaluation of the application. The information contained in an application will be protected by NIH from unauthorized disclosure, consistent with the need for peer review of the application (including the agreement by peer reviewers and Advisory Council members to the NIH confidentiality and nondisclosure rules); and the requirements of the FOIA and Privacy Act (5 U.S.C. 552 as discussed below). However, if a grant is awarded as a result of or in connection with an application, the Federal government has the right to use or disclose the information to the extent authorized by law. This restriction does not limit the Federal government's right to use the information if it is obtained without restriction from another source.

2.3.11.2.1 Privacy Act

The Privacy Act of 1974, 5 U.S.C. 552a (as amended), and its implementing regulations (45 CFR 5b) provide certain safeguards for information about individuals maintained in a system of records (i.e., information may be retrieved by the individual's name or other identifying information). These safeguards include the rights of individuals to know what information about them is maintained in Federal agencies' files (hard copy or electronic) and how it is used, how they may obtain access to their records, and how to correct, amend, or request deletion of information in their records that is factually incorrect.

Records maintained by NIH with respect to grant applications, grant awards, and the administration of grants are subject to the provisions of the Privacy Act. The NIH Privacy Act Systems of Records that covers NIH grant records is:

This system of record provides guidance on requirements for the management of applicable grant records in NIH's possession and include appropriate routine uses of such information. It also includes requirements for safeguarding the records and for record retention and disposal.

Parties other than PD/PIs may request the release of Privacy Act grant records. Such requests are processed under FOIA. For example, information requested by co-investigators in grant applications is released to them only when required under FOIA because they have no right of access under the Privacy Act. When releasing information about an individual to a party other than the subject of the file, NIH will balance the individual's right to privacy with the public's right to know as provided by the FOIA.

Records maintained by recipients ordinarily are not subject to the requirements of 45 CFR 5b.

2.3.11.2.2 The Freedom of Information Act

The Freedom of Information Act, 5 U.S.C. 552, and implementing HHS regulations (45 CFR 5) require NIH to release certain grant documents and records requested by members of the public, regardless of the intended use of the information. These policies and regulations apply to information in the possession of NIH. Generally NIH cannot require recipients or contractors under grants to permit public access to their records. An exception related to certain research data is described in this subsection.

NIH generally will release the following types of records pursuant to a FOIA request:

NIH generally will withhold the following types of records or information in response to a FOIA request:

Applicants are instructed to identify proprietary information at the time of submission of an application. If, after receiving a FOIA request, NIH has substantial reason to believe that information in its records could reasonably be considered exempt from release, the appropriate NIH FOI office will notify the applicant or recipient, through the PD/PI, before the information is released. In the case of multiple PD/PI's the Contact PD/PI will be notified and is responsible for coordinating any response to the notice. Multiple responses to the notice will not be accepted. If an applicant fails to identify proprietary information at the time of submission as instructed in the application guide, a significant substantive justification will be required to withhold the information if requested under FOIA. The PD/PI will be given five (5) working days to identify potentially patentable or commercially valuable information that the PD/PI believes should not be disclosed. Any such submission must be specific as to the nature and type of commercial harm that will result if the requested information is released. Submissions that merely state in general terms that the grant application or portions should not be released will not be honored. If the PD/PI does not respond within that time period, the grant will be prepared for release in accordance with applicable FOIA policies and released to the requester. If the PD/PI does identify commercial or proprietary information an NIH official will review that response. After NIH consideration of the response, the PD/PI and recipient will be informed if NIH does not agree with the PD/PI's position. If a document contains both disclosable and non-disclosable information, the non-disclosable information will be redacted and the balance of the document will be disclosed.

The HHS regulations implementing FOIA provide that only the NIH FOI Officer may deny requests for information. Requests for information, the release of which is believed to be exempt under FOIA, are referred to the NIH FOI Officer along with written documentation of the rationale for nondisclosure. If the NIH FOI Officer determines that the requested information is exempt from release under FOIA, the requester may appeal that determination to the Deputy Assistant Secretary for Public Affairs (Media), HHS. Additional information on the FOIA process is available at the NIH FOI Office Web site (http://www.nih.gov/icd/od/foia).

2.3.11.2.3 Access to Research Data

NIH handles requests for the release of research data by certain types of recipients as FOIA requests. The term "research data" is defined as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings. It does not include preliminary analyses; drafts of scientific papers; plans for future research; peer reviews; communications with colleagues; physical objects (e.g., laboratory samples, audio or video tapes); trade secrets; commercial information; materials necessary to be held confidential by a researcher until publication in a peer-reviewed journal; information that is protected under the law (e.g., intellectual property); personnel and medical files and similar files, the disclosure of which would constitute an unwarranted invasion of personal privacy; or information that could be used to identify a particular person in a research study.

As required by 45 CFR 75.322, recipients that are institutions of higher education, hospitals, or non-profit organizations must release research data first produced in a project supported in whole or in part with Federal funds that are cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., regulations and administrative orders). If the data are publicly available, NIH directs the requester to the public source. Otherwise, the IC FOI coordinator handles the request, consulting with the affected recipient and the PD/PI. This requirement also provides for assessment of a reasonable fee to cover recipient costs and (separately) the NIH costs of responding.

This requirement to release research data does not apply to commercial organizations or to research data produced by State or local governments. However, if a State or local governmental recipient contracts with an IHE, hospital, or non-profit organization, and the contract results in covered research data, those data are subject to the disclosure requirement.

Additional information is available on the NIH Web site at http://grants.nih.gov/grants/policy/data_sharing/index.htm. (Also see Administrative Requirements-Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources.)

2.3.12 Protecting Sensitive Data and Information Used in Research

Recipients of NIH funds are reminded of their vital responsibility to protect sensitive and confidential data as part of proper stewardship of federally funded research, and take all reasonable and appropriate actions to prevent the inadvertent disclosure, release or loss of sensitive personal information. NIH advises that personally identifiable, sensitive, and confidential information about NIH-supported research or research participants not be housed on portable electronic devices. If portable electronic devices must be used, they should be encrypted to safeguard data and information. These devices include laptops, CDs, disc drives, flash drives, etc. Researchers and institutions also should limit access to personally identifiable information through proper access controls such as password protection and other means. Research data should be transmitted only when the security of the recipient's systems is known and is satisfactory to the transmitter. See also Public Policy Requirements and Objectives-Federal Information Security Management Act.