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Part I: NIH Grants—General Information – File 2 of 2

2 THE NATIONAL INSTITUTES OF HEALTH AS A GRANT-MAKING ORGANIZATION

NIH is the steward of medical and behavioral research for the Nation. Its mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. NIH operates under the general policy guidance of the Department in carrying out its mission, which is accomplished through the conduct and support of biomedical and behavioral research, research training, research infrastructure, and communications. These efforts take place intramurally (primarily at NIH) and extramurally (through grants, cooperative agreements, and contracts awarded to institutions of higher education, governmental organizations, non-profit research organizations, for-profit organizations, and individuals). NIH also works closely with other HHS components and other Federal departments and agencies. HHS components include SAMHSA, FDA, CDC, IHS, AHRQ, HRSA, ACF, ACL, OPHS, and CMS, among others.

HHS develops, issues, and maintains regulations that govern the Department's grants process. Among these are the regulations that implement the OMB Circular A-102 common rule, applicable to grants to State, local, and Indian tribal governments, and OMB Circular A-110 (relocated to 2 CFR 215), applicable to grants to institutions of higher education, hospitals, and other non-profit organizations. These regulations are codified at 45 CFR 74 (Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non-Profit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments, and Indian Tribal Governments) and 45 CFR 92 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments). Although the government-wide requirements do not cover grants to for-profit organizations, HHS has included them in the coverage of 45 CFR 74. The above regulations provide the framework for the terms and conditions of NIH awards as specified in Part II.

NIH is organized into ICs, which have their own mission and functions, separate appropriations, and statutory authorities. The ICs that award grants and their points of contact are listed in Part III. Although the ICs operate under the same general grant process and requirements, applicants and grantees need to be aware of differences that may exist. This information may be obtained from NIH IC staff. The policies and procedures generally applicable to NIH grants are set forth in the NIHGPS.

2.1 Roles and Responsibilities

NIH, as a Federal grantor agency, is responsible to Congress and the U.S. taxpayer for carrying out its mission in a manner that not only facilitates research but does so cost-effectively and in compliance with applicable rules and regulations. NIH seeks to ensure integrity and accountability in its grant award and administration processes by relying on a system of checks and balances and separation of responsibilities within its own staff and by establishing a similar set of expectations for grantee organizations.

The following subsections highlight the major functions and areas of responsibility of Federal and grantee staffs. NIH recognizes that additional staff members in a number of different organizations may be involved in grant-related activities; however, this section details only the major participants representing the Federal government and the grantee. The responsibilities of CSR staff members, who are involved only in the initial review phase of the peer review process, are described in The Peer Review Process—Initial Review—Responsibilities. The responsibilities of other offices, such as OHRP, are described in Part II as applicable.

2.1.1 NIH and HHS Staff

The roles and responsibilities of NIH and HHS participants are as follows:

• Grants Management Officer. The GMO whose name appears in the NoA is the NIH official responsible for the business management and other non-programmatic aspects of the award. These activities include, but are not limited to, evaluating grant applications for administrative content and compliance with statutes, regulations, and guidelines; negotiating grants; providing consultation and technical assistance to applicants and grantees, including interpretation of grants administration policies and provisions; and administering and closing out grants. The GMO works closely with his or her counterparts in other NIH ICs and with the designated PO. The GMO is the focal point for receiving and acting on requests for NIH prior approval or for changes in the terms and conditions of award, and is the only NIH official authorized to obligate NIH to the expenditure of Federal funds or to change the funding, duration, or other terms and conditions of award. A Chief Grants Management Officer is the principal GMO who provides leadership to an organizational component that is responsible for the business and fiscal management of the ICs grant portfolio. Generally, the CGMO will have the authority to appoint and exercise line authority over one or more GMOs. At NIH each awarding component has a CGMO.
• Grants Management Specialist. The GMS whose name appears in the NoA is an agent of the GMO and is assigned responsibility for the
  day-to-day management of a portfolio of grants.
• Program Official. The PO is responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO's responsibilities include, but are not limited to, development of research and research training programs to meet the IC's mission; coordination with CSR/IC SROs; and post-award administration, including review of progress reports, participation in site visits, and other activities complementary to those of the GMO. The PO and the GMO work as a team on many of these activities.
• Scientific Review Officer. SROs are health science administrators who manage the activities of SRGs, including CSR study sections. For the SRG for which he or she is responsible, the SRO reviews applications for completeness and conformity to requirements, ensures that adequate numbers of reviewers with appropriate expertise are available for application review, assigns applications to individual reviewers as discussion leaders and for preparation of written critiques, and serves as the overall point of contact with applicants during the initial phase of the peer review process, i.e., until the conclusion of the SRG meeting.
• Other NIH, HHS and Federal Agency Staff. In addition to the GMO and PO, the grantee may be required to interact with other NIH or HHS staff members or offices with respect to its organization-wide systems and/or individual transactions. These include the office responsible for negotiating F&A costs and research patient care rates, typically the cognizant DCA office, ONR, or DFAS; OIG; OHRP; ORI; OLAW; and OPERA. Staff members in these offices generally coordinate with the GMO, but they are responsible for discrete areas of specialization and are not required to channel their communications with the grantee through the GMO. Part III includes a list of these organizations and their addresses and telephone numbers. ONR is the cognizant agency for negotiation of F&A costs for some NIH grantees.

2.1.2 Grantee Staff

Overall responsibility for successfully implementing an NIH grant is a shared responsibility of the PD/PI(s), the AOR, and the Research Administrator. As key members of the grant team, they respectively lead the scientific and administrative aspects of the grant. While communications can be conducted with Research Administrators and other institutional staff, NIH staff members conduct official business only with the designated PD/PI(s) and AORs. The roles and responsibilities of grantee participants are as follows:

• Authorized Organization Representative. The AOR is the designated representative of the grantee organization in matters related to the award and administration of its NIH grants, including those that require NIH approval. The AOR should ascertain and assure that the materials the applicant organization are submitting on behalf of the PD/PI are the original work of the PD/PI and have not been used by other individuals in the preparation and submission of a similar grant application. In signing a grant application, this individual certifies that the applicant organization will comply with all applicable assurances and certifications referenced in the application. This individual's signature on the grant application further certifies that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application. (Also see Legal Implications of Applications.) This individual also is responsible to NIH for ensuring that the organization complies with applicable Federal laws and regulations, including required certifications and assurances, its application, and the terms and conditions of individual awards. For applications submitted electronically through Grants.gov, the signature of the AOR is documented as part of the electronic submission process and is authenticated through the Grants.gov registration process. In the eRA Commons, this individual holds the Signing Official role. Although NIH requires that the grantee organization designate such an official, NIH does not specify the organizational location or full set of responsibilities for this official.
• Program Director/Principal Investigator. A PD/PI is an individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award. The applicant organization may designate multiple individuals as PD/PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports. The presence of more than one identified PD/PI on an application diminishes neither the responsibility nor the accountability of any individual PD/PI.
  
  When a single PD/PI is designated, that individual is not required to be an employee of the applicant organization. However, because the grant, if awarded, is made to the organization, the applicant organization must have a formal written agreement with the PD/PI that specifies an official relationship between the parties even if the relationship does not involve a salary or other form of remuneration. If the PD/PI is not an employee of the applicant organization, NIH will assess whether the arrangement will result in the organization being able to fulfill its responsibilities under the grant, if awarded.
  
  When multiple PD/PIs are designated, NIH requires identification of one PD/PI who will be designated as the Contact PD/PI. This person is responsible for communication between the PD/PIs and the NIH. Serving as Contact PD/PI confers no special authorities or responsibilities within the project team. The Contact PD/PI must meet all eligibility requirements for PD/PI status. They are not required to be an employee of the applicant organization. However, as with the single PD/PI model, if the Contact PD/PI is not an employee, the applicant organization must have a formal written agreement with the Contact PD/PI that specifies an official relationship between the parties. This same principle applies to all PD/PIs at the applicant organization; e.g., they need not be employees; however the applicant organization must have a formal written agreement in place.
  
  When multiple PD/PIs are involved at different organizations, only the Contact PD/PI is required to have the official relationship with the applicant organization. PD/PIs in the leadership team at other organizations must have a documented relationship with a consortium organization, but need not be employees. Any consortium agreement must address the unique aspects to these individuals holding the PD/PI role.
  
  PD/PIs are members of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award. They work closely with designated officials within the grantee organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support of research findings in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements. NIH encourages PD/PIs to maintain contact with the NIH PO with respect to the scientific aspects of the project and the GMO/GMS concerning the business and administrative aspects of the award. The NIH staff contacts list located at http://grants.nih.gov/grants/staff_list_grants_admin.htm#ics includes contact information for NIH grants management and program staff at each IC.
• Research Administrator. The Research Administrator acts as a local agent of the AOR and/or PD/PIs providing day-to-day grant-related support. Depending on the structure of the organization, this individual can be located centrally or within an organizational component such as a Department.

2.2 eRA Commons

eRA Commons is an online interface where grant applicants, grantees and Federal staff at NIH and grantor agencies are able to conduct their research administration business electronically as well as access and share administrative information relating to research grants. While applicants use Grants.gov to find and apply for grants; the eRA Commons retrieves the application or proposal information from Grants.gov, compiles it into a consistent application format and makes then it available to applicants and NIH staff for electronic research administration purposes.

Access to the eRA Commons is vital for all steps in the NIH grant administration process. Following application submission, the eRA Commons becomes the primary site for accessing grant information such as Institute/Center assignments, review outcomes, Summary Statements, and Notices of Award. The eRA Commons also provides electronic business processes such as Internet Assisted Review, submission of Just-In-Time material, submission of electronic SNAP progress reports (eSNAP), submission of Financial Reports (FSRs/FFRs), submission of notification of extensions without funds, and submission of Closeout documents. Appropriate user roles are assigned to registered individuals depending on the responsibilities assigned to them by the grantee organization.

2.2.1 eRA Commons Registration

An organization and PD/PI(s) must complete a one-time registration in the Commons. Institutional/organizational officials are responsible for registering PD/PI(s) in the eRA Commons. PD/PI(s) should work with their AOR (also known as the Signing Official in the eRA Commons) to determine their institutional/organizational process for registration.

IMPORTANT: Organizations registering in the eRA Commons for the first time should allow 2-4 weeks to complete the registration process.

2.2.1.1 eRA Commons Registration for the Organization

Prospective applicant organizations should also see Legal Implications of Applications before beginning the eRA Commons registration process.

Organizations may verify their current registration status by accessing the "List of Grantee Organizations Registered in eRA Commons" at http://era.nih.gov/commons/quick_queries/index.cfm#commons. This listing can be accessed without logging into the Commons. The list includes organization name and location, the NIH-assigned IPF Code, and any DUNS number that has been stored in the institutional profile for that organization.

To register an Organization in the eRA Commons an AOR should follow the procedures found on the eRA Commons homepage at https://commons.era.nih.gov/commons/ under the link "Grantee Organization Registration."

Once an organization is registered, information in the Institutional Profile can be maintained through the Commons.

During this registration process, NIH may make a preliminary assessment of applicant organization eligibility. Applicants should be prepared to establish their eligibility to receive and administer all awards (that are applied for), and NIH may deny registration if an organization is determined ineligible. Note, acceptance of an organization’s registration in the Commons does not mean an organization is an acceptable grantee for a particular program. That assessment will be made by the NIH awarding component prior as part of the pre-award process. See Determining Applicant Organization Eligibility for additional information.

Foundations that represent already existing grantee organizations, or a newly formed consortium where the consortium members are already individually recognized as NIH grantee organizations present unique and complex situations and should contact DGP, OPERA before attempting to separately register as a new applicant organization.

2.2.1.2 eRA Commons Registration for the PD/PI

The individual(s) designated as the PD/PI(s) on the application must also be registered in the Commons. The PD/PI(s) must hold a PD/PI eRA Commons role and be affiliated with the applicant organization. The initial registration must be done by an AOR who has the SO role in the Commons or other authorized accounts administrators at the organization. However, after the initial registration process is complete, it becomes the responsibility of each individual to maintain the information in his/her personal profile.

Designating the PD/PI role in the eRA Commons provides the individual with the administrative authority needed to see pertinent information regarding an application (e.g., summary statements, scores, electronic submission status, etc.). The PD/PI role within the eRA Commons is necessary to complete the grant application process, to view the impact score and summary statement, and if an award is made, to complete required post-award actions such as submission of a progress report. The PD/PI may delegate certain authorities to other individuals.

Users should only have one PD/PI eRA Commons account. If the PD/PI has already been registered in eRA Commons by an organization other than the organization submitting an application, a separate eRA Commons registration with the submitting organization is not necessary. However, the submitting organization must take steps to affiliate the individual with that organization so that the individual can view and access data records for those applications.

For more information on the features of the eRA Commons, including links to resources such as user guides and frequently asked questions, see the eRA Commons webpage at: http://era.nih.gov/commons/index.cfm.

2.2.1.3 eRA Commons Registration for Individuals Serving in a Postdoctoral Role

Any individual with a postdoctoral role who participates in a NIH-funded project for at least one person month or more must also be registered in the eRA Commons with the Postdoc Role. This is required regardless of whether salary is actually charged to the project. For individuals supported on a particular research grant, this could include project roles such as Postdoctoral Associate and other similar Postdoctoral positions. Note, this eRA Commons Postdoc role should NOT be used for individuals submitting Individual Fellowships; the PD/PI role is used for those submissions.

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.

• New Application (Type 1). A request for financial assistance for a project or activity that is not currently receiving NIH support and must compete for support. A new application is being submitted for the first time.
• Renewal (Type 2). A request for additional funding for a period subsequent to that provided by a current award. A renewal application competes with all other applications and must be fully developed as though the applicant is applying for the first time.
• Revision (Type 3). A request for an increase in support in a current budget period for expansion of the project’s approved scope or research protocol. The request may specify budgetary changes required for the remainder of the project period as well as for the current budget period. Applications for revisions are not appropriate when the sole purpose is to restore awards to the full SRG-recommended level if they were administratively reduced by the funding agency. A revision application should not be submitted until after the original application has been awarded and may not extend beyond the term of the current award period. A revision application must have the same title as the currently funded grant. (A Type 3 prefix also refers to a request/award for a non-competing administrative supplement [see Administrative Requirements—Changes in Project and Budget—Prior Approval Requirements—Need for Additional NIH Funding without Extension of Budget and Project Period].)
• Resubmission. An unfunded application that the applicant has modified following initial review and resubmitted for new consideration. Before a resubmission application can be submitted, the PD/PI must have received the summary statement from the previous review. A resubmission application may be submitted for any of the three preceding types of applications. See Application Information and Processes—Policies Affecting Applications for other policies affecting Resubmissions. NIH allows only one resubmission application.
• Non-Competing Continuation Progress Report (Type 5). A non-competing progress report is required to continue support of a PHS grant for the second or subsequent budget period within an approved competitive segment (see Administrative Requirements—Monitoring—Reporting—Non-Competing Continuation Progress Reports).

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.

• Program Announcement (PA). A PA is a formal statement about a new or ongoing extramural activity or program. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or program, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes. NIH may also make funds available through PARs (PAs with special receipt, referral, and/or review considerations) and PASs (PAs with set-aside funds).
  
  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.
• Request for Applications (RFA). An RFA is a formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, whether cost sharing is required, and the application submission date(s). For cooperative agreements, the RFA will describe the responsibilities and obligations of NIH and awardees as well as joint responsibilities and obligations. Applications submitted in response to an RFA are usually reviewed by an SRG specially convened by the awarding component that issued the RFA.
• Parent Announcements. Electronic submission of applications requires that applications must be associated with a specific FOA. Therefore, NIH omnibus parent announcements are provided for applicants to submit investigator-initiated (unsolicited) applications. Responding to such an omnibus or umbrella parent FOA ensures that the correct application package is used and enables NIH to receive the application from Grants.gov. This process in no way diminishes the interest of NIH ICs in investigator-initiated, unsolicited research grant applications. Parent announcements are NIH-wide, but some ICs may limit their participation; therefore prospective applicants should check the announcement to determine IC participation. For institute-specific opportunities in a particular area of science, search the NIH Guide for Grants and Contracts.

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 (http://www.grants.gov/applicants/find_grant_opportunities.jsp). 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.

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 grantee 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 grantee 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 otherwise noted in a particular FOA, 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

For original new applications (i.e., never submitted) and competing renewal applications, the NIH will accept only a single resubmission (A1) to the original application. If an applicant submits an A2 application for which only one resubmission is allowed, the A2 application will be administratively withdrawn by CSR and the principal investigator and applicant AOR will be notified. A resubmission must be submitted within 37 months of the original due date of the initial submission.

Applicants who do not receive funding after two submissions (i.e., the original and the single resubmission) may resubmit but only if the application is fundamentally changed to qualify as new.

A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in an amended application. A new application should include substantial changes in all sections of the Research Plan, particularly in the Specific Aims and the Research Strategy sections. There should be fundamental changes in the questions being asked and/or the outcomes examined. Changes to the Research Plan should produce a significant change in direction and approach for the research project. In the case of institutional Training and institutional Career Development applications, there must be a significant or substantial change in the programmatic, leadership, administrative, or other critical aspect of the program. Re-wording the title and/or Specific Aims or incorporating changes that are in response to comments in the previous summary statement does not constitute a substantial change in scope or content. Requests for review by a different review committee or funding consideration by a different NIH IC are not sufficient reasons to consider an application as new. Submission to a different FOA is also 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.

Applications are screened multiple times and checked to determine if the application is a new application, not simply another version of a project that has already received the maximum number of reviews. The first check is done within the Division of Receipt and Referral, CSR. Subsequent checks are performed by the SRO in charge of the review meeting and by IC program staff.

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.

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:

• Revised budget page(s) (e.g., change in budget request due to a new funding or institutional acquisition of equipment)
• Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)
• Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator
• Adjustments resulting from natural disasters (e.g., loss of an animal colony)
• Adjustments resulting from change of institution (e.g., PD/PI moved to another university)
• News of an article accepted for publication (a copy of the article should not be sent)

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.

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. 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.

For all types of applications, materials such as devices, videos, or other media that are considered essential to the review and generally are accepted by the IC for that type of application will be accepted at the discretion of the SRO managing the review.

Additional materials should be sent as a PDF attachment to an e-mail. E-mail communication is strongly encouraged whether the original application was submitted on paper or through Grants.gov. NIH recommends producing the documents electronically using text or word-processing software and then converting the document to PDF. This will allow the text to be searched electronically (i.e. do not scan files that have text as an image, scan as text file only). If e-mail is not feasible, send in a hard copy.

The materials must be submitted to the NIH SRO one month (30 calendar days) prior to the peer review meeting. Post submission materials will be not be accepted if fewer than 30 calendar days remain before the peer review meeting. The content of the additional materials may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or organizational officials. However, the communication to the SRO must include the concurrence of the AOR of the applicant institution; either the AOR should send the materials directly to the SRO, or the AOR may send their concurrence to the PD/PI who forwards the materials and the concurrence to the SRO. Materials sent without evidence of such concurrence will not be accepted. A communication from the PD/PI only or with a "cc" to the AOR will not be accepted.

The original application is kept intact. The SRO is responsible for uploading acceptable additional materials in the official electronic grant file. The PD/PI can check the application via the eRA Commons to see these materials in the section titled “Additions for Review”. This allows the information to be available to reviewers in a secure manner. Post-submission grant application materials used in the peer review process will be retained as part of the official grant file and remain part of the permanent record for that application.

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.

2.3.7.8 DUNS Number and CCR Registration Requirements

All applicant organizations must obtain 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 Central Contractor Registry (CCR) 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. CCR 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 CCR internet site at https://www.sam.gov/portal/public/SAM/.

If an award is granted, the grantee 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 grantee organization.

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).

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.

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.

• Regular Standard Submission/Receipt Dates. To be considered applications must be received at the NIH within two weeks of the standard submission date.
• Expedited Standard Submission/Receipt Dates. To be considered applications must be received at the NIH within one week of the standard submission date.
• NIH will not consider late applications for the Special Receipt Dates for RFAs and PARs.
• NIH does not expect to accept any applications received beyond the window of consideration.

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

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. 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. 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.

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:

• Your institution’s Office of Sponsored Research, Compliance Office, or other responsible office,
• The NIH CGMO listed in the NoA for the IC that funded the grant,
• The DGCO/OPERA/OER.

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 grantee 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 grantee; submitting false financial reports; and submitting false financial data in bids submitted to the grantee (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 grantee 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, grantee, 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 parts 74 and 92.

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 grantee 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 and the requirements of the FOIA and Privacy Acts (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:

• 09-25-0036, Extramural Awards and Chartered Advisory Committees: (IMPAC 2), Contract Information (DCIS), and Cooperative Agreements Information

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 grantees 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 grantees 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:

• Funded applications and funded progress reports, including award data.
• Final reports that have been transmitted to the grantee organization of any audit, survey, review, or evaluation of grantee performance.

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

• Pending competing grant applications
• Unfunded new, renewal, and revision applications
• Financial information pertaining to project personnel, such as institutional base salary information
• Information pertaining to an individual, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy
• Predecisional opinions in interagency or intraagency memorandums or letters expressed by Federal government officers, employees, or consultants
• Evaluative portions of site visit reports and peer review summary statements, including impact scores
• Trade secrets and commercial, financial, and otherwise intrinsically valuable items of information that are obtained from a person or organization and are privileged or confidential
• Information which, if released, would adversely affect the competitive position of the person or organization
• Patent or other valuable commercial rights of the person or organization.

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 grantee, 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 grantee 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 74.36, grantees 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 grantee and the PD/PI. This requirement also provides for assessment of a reasonable fee to cover grantee 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 grantee contracts with an educational institution, 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.

2.4 The Peer Review Process

Competing applications for NIH grants and cooperative agreements, including those renewals and revisions, are subject to peer review as required by sections 406 and 492 of the PHS Act, the NIH Reform Act of 2006, or by NIH policy. NIH policy is intended to ensure that applications for funding submitted to the NIH are evaluated on the basis of a process that is fair, equitable, timely, and conducted in a manner that strives to eliminate bias. The peer review system used by NIH, often referred to as the “dual review system,” is based on two sequential levels of review for each application—initial review by an IRG or SRG, and a second level of review by the IC National Advisory Council/Board.

The NIH peer review process has evolved over the years to accommodate changes in workload, resource constraints, and recommendations of various groups that have studied it. However, the underlying basis for the system—to provide a fair and objective review process in the overall interest of science—has not changed. Information concerning NIH’s peer review process may be found at http://grants.nih.gov/grants/peer/peer.htm. Information also is available from GrantsInfo, or from OEP (see Part III).

2.4.1 Initial Review

2.4.1.1 Responsibilities

The DRR in the CSR is the receipt point for all competing grant applications submitted to NIH, whether the peer review will be conducted by CSR or by an IC. The primary determining factors in whether CSR or an IC will be responsible for the peer review are the announcement type, the support mechanism, and/or the program. In general, CSR is responsible for the initial review of research project grant applications (including AREA applications), Kirschstein-NRSA individual fellowship applications, and SBIR/STTR applications, while the ICs handle the initial review of conference grant applications, applications resulting from RFAs, and program project and center grant applications.

CSR also may review other types of applications at IC request. When the IC is responsible for the initial review, CSR reviews the application for completeness, and the scientific review office of the soliciting IC reviews the application for responsiveness to the RFA, coordinates the initial technical review, and prepares the summary statements.

CSR Referral Officers, who are senior health science administrators with both research and scientific review experience, assign each application to one or more ICs for potential funding and to an IRG or SRG for initial review of the scientific merit of the application. These determinations are made on the basis of the application’s contents, the referral guidelines, and any written request by the applicant organization (accompanying the application) for a specific study section or IC assignment.

SRGs, including CSR study sections, are organized by scientific discipline or current research areas and are managed by health scientist administrators functioning as SROs. Generally, study sections are chartered groups composed of formally appointed members serving multiyear terms, to which the SRO often adds temporary members or other additional reviewers. Ad hoc SEPs are formed to review applications that cannot be reviewed by a standing review group or study section because they require special expertise or involve other special circumstances.

SRGs, whether study sections or SEPs, are primarily composed of non-federal scientists who have expertise in relevant scientific disciplines and are actively engaged in research. NIH’s conflict-of-interest and confidentiality of information requirements for reviewers are intended to promote an unbiased review process by minimizing even the appearance of a conflict of interest and by restricting the use of privileged application information.

Applicants are notified by e-mail that the application has been received and that they may have access to the SRO, SRG, and IC assignments for the application in the eRA Commons. At this time, applicants may request reconsideration of the SRG and IC assignment. Applicants also are notified by e-mail to check eRA Commons for any change in the application’s SRG or IC assignment, as well as a change in Council date. Once the assignment process is completed, the SRO is the contact for all communication with the applicant until the conclusion of the SRG meeting. An applicant organization may withdraw an application from consideration at any time during the review process. A request to withdraw an application must be signed by the PD/PI and an AOR.

In preparation for the initial review, SROs review applications to determine whether they are complete and conform to administrative requirements. For each reviewable application, they then assign (from among the standing and temporary members) at least three reviewers to write a critique of the application and to be prepared to discuss the application in detail.

Following the initial review, the SRO generally prepares a summary statement for most applications reviewed. The summary statement includes the reviewers’ written comments, and, for scored applications, a summary of strengths and weaknesses, other summary highlights of the discussion, and an impact score. Summary statements are then provided to the IC’s program staff and the PD/PI.

2.4.1.2 Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the five scored review criteria, and additional review criteria (as applicable for the project proposed). All of the criteria, weighted as appropriate for each application or as described in the FOA, will be considered when assigning the overall impact score.

2.4.1.3 Scored Review Criteria

The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. For research grant applications, and most other types of applications, reviewers judge the overall impact to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, taking into account, among other pertinent factors: Significance, Investigator(s), Innovation, Approach, and Environment. These scored review criteria may not be applicable for some types of applications. When these criteria are not applicable, the FOA will include the specific review criteria.

Reviewers will consider each of the five criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

• Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the application are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
• Investigator(s). Are the PD/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
• Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
• Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
• Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

2.4.1.4 Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

• Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
  
  For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
• Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
• Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
• Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
• Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
• Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous SRG are adequate and whether substantial changes are clearly evident.
• Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

2.4.1.5 Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

• Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
• Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the select agent(s) to be used in the proposed research, 2) the registration status of all entities where select agent(s) will be used, 3) the procedures that will be used to monitor possession, use and transfer of select agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the select agent(s).
• Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
• Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome-Wide Association Studies (GWAS).

Although the review criteria are intended for use primarily with investigator-initiated research project grant applications (e.g., R01 and P01), including those in response to PAs, to the extent reasonable, the criteria also will form the basis of the review of solicited applications and non-research activities. However, for some activities (e.g., construction grants), the use of these criteria may not be feasible. Applications also may be reviewed against other pertinent factors as stated in RFAs or PAs.

2.4.2 Appeals of Initial Scientific Review

To preserve and underscore the fairness of the NIH peer review process, NIH has established a peer review appeal system to provide applicants the opportunity to see reconsideration of the initial review results if, after consideration of the summary statement, they believe the review process was procedurally flawed. The NIH policy for appeals of initial peer review applies to all competing applications submitted to the NIH for support, for the January 25, 2011 due date and thereafter. It does not apply to appeals of the technical evaluation of Research and Development contract projects through the NIH peer review process, appeals of NIH funding decisions, or appeals of decisions concerning extensions of MERIT awards. In addition, NIH will not review a resubmission application when an appeal of initial peer review is pending on the original application. Appeals of initial peer review outcome will not be accepted for applications in response to an RFA.

An appeal is a written communication from a Program Director/Principal Investigator (PD/PI) and/or applicant institution that meets the following four criteria: 1) is received after issuance of the summary statement and up to 30 calendar days after the second level of peer review, 2) describes a flaw or perceived flaw in the review process for a particular application, 3) is based on one or more of four allowable issues (described below), and 4) displays concurrence from the Authorized Organization Representative (AOR).

An applicant who is concerned about procedural aspects related to the completed initial peer review of his or her application first should consider the comments in the summary statement, and then should contact the appropriate NIH Program Official (PO). Following discussion of concerns with the PO, if the PD/PI and/or an official of the applicant organization wishes to appeal the outcome of the initial peer review process, an appeal letter must be submitted, either in hard copy or electronically, to the PO. The appeal letter must display concurrence from the AOR of the applicant organization for the application. Although the content of the appeal letter may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or an organizational official(s) (not necessarily the AOR), the AOR must send the letter directly to the PO, or must send his/her concurrence to the PD/PI who will forward the materials and AOR concurrence to the PO. A communication from the PD/PI or official of the applicant organization (other than the AOR) only or with a "cc" to the AOR will not be accepted. The PO will send the PD/PI and/or institutional official, and AOR, an acknowledgement letter within 10 days of receipt of the appeal letter.

An appeal letter will be accepted only if the letter 1) describes the flaws in the review process for the application in question, 2) explains the reasons for the appeal, and 3) is based on one or more of the following issues related to the process of the initial peer review:

• Evidence of bias on the part of one or more peer reviewers.
• Conflict of interest, as specified in regulation at 42 CFR 52h.5 "Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects", on the part of one or more non-Federal peer reviewers.
• Lack of appropriate expertise within the SRG.
• Factual error(s) made by one or more reviewers that could have altered the outcome of review substantially.

Appeal letters based solely on differences of scientific opinion will not be accepted. A letter that does not meet these criteria and/or does not include the concurrence of the AOR will not be considered an appeal letter, but rather a grievance. The IC will handle grievances according to IC-specific procedures.

If review staff and program staff do not support the appeal, or do not agree on its merit, the PD/PI and/or an institutional official (not necessarily the AOR) may elect to withdraw the appeal letter. The request to withdraw an appeal letter must be submitted either in hard copy or electronically to the PO, and must display concurrence from the AOR of the applicant organization for the application. Although the content of the request may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or an organizational official(s) (not necessarily the AOR), the AOR must send the request directly to the PO, or must send his/her concurrence to the PD/PI who will forward the materials and his/her concurrence to the PO. A communication from the PD/PI or institutional official (other than the AOR) only or with a "cc" to the AOR will not be accepted.

If review staff and program staff do not support the appeal, or do not agree on its merit, and the appeal letter is not withdrawn, the appeal letter will be made available to Council. The IC may not deny the PD/PI or applicant organization the opportunity to have an appeal letter made available to Council. Only two outcomes are possible following consideration of an appeal letter by Council:

• The Council may concur with the appeal, and recommend that the application be re-reviewed.
• The Council may concur with the SRG's recommendation and deny the appeal. Although factual errors or other issues may be evident, the Council may determine that these factors were unlikely to alter the final outcome of the SRG and deny the appeal. No action by the Council is equivalent to concurrence with the SRG's recommendation and denial of the appeal.

The recommendation of Council concerning resolution of an appeal is final and will not be considered again by the NIH through this or another process.

The Executive Secretary for the Council will communicate the Council recommendation concerning an appeal to the PD/PI, AOR, and NIH staff with a need to know. If the appeal letter was received by the IC deadline, the PD/PI and AOR will receive a written explanation of the resolution no later than 30 calendar days after the Council meeting. If the appeal letter was received after the IC deadline, the Executive Secretary will provide, no more than 30 calendar days after the date when the appeal letter was received, a written explanation of the IC's plan for making the appeal available to Council.

If the Council recommended that the application be re-reviewed, the original application will be re-reviewed without additional materials or modifications. The application may be re-reviewed by the same or a different SRG, depending on the flaws in the original review process that led to the appeal. In most cases, the re-review will entail re-assignment to a subsequent review round and delay in the final funding decision. The outcome of the re-review is final and cannot be appealed again.

On occasion, and for specific circumstances, the NIH may suspend temporarily the policy and process for handling appeals of NIH initial peer review. Such decisions will be announced in NIH Guide Notices and/or the relevant Funding Opportunity Announcements when they are issued in the NIH Guide for Grants and Contracts.

2.4.3 National Advisory Council or Board Review

Summary statements for those applications recommended for further consideration are presented to the assigned IC National Advisory Council or Board (hereafter “Council”) for use in the second level of review. Council members include senior scientists with broad experience and members of the public with general knowledge of, and interest in, the IC’s mission. The Council reviews applications not only for scientific and technical merit, as judged by the SRG, but also for relevance to the IC’s programs and priorities. The Council may concur with the SRG’s recommendation, may decide not to recommend an application on the basis of program or policy considerations, or may recommend deferral of an application and refer it back to the SRG for re-review.

In addition, Council members will receive a list of competing applications that will be considered for funding from PD/PIs that meet the threshold for Special Council Review. These are investigators who currently receive $1 million or more in direct costs of NIH funding to support Research Project Grants. Council members will be asked to recommend consideration of funding for applications that afford a unique opportunity to advance research which is both highly promising and distinct from the other funded projects from the PD/PI. This does not represent a cap to NIH funding.

With very limited exception, an application may not be considered for funding unless it has received a favorable recommendation by both the SRG and the Council. For some applications (e.g., Kirschstein NRSA Fellowship applications) the second level of review is conducted by senior level IC staff.

2.4.4 Disposition of Applications

All incomplete applications, non-compliant modular applications, and applications determined to be nonresponsive to FOA requirements will not be reviewed. If the FOA remains open with subsequent submission dates, the applicant may resubmit a corrected or complete version of an investigator-initiated application for consideration in the next review cycle.

Following the initial review, the summary statement will be available to the PD/PI in the eRA Commons. The IC Director or designee is the official who has the authority to make final award decisions from among those applications receiving a favorable initial review and Council recommendation. If an application has been recommended for further consideration but is not expected to be funded in the current cycle, the application may be held by NIH for one or more additional cycles and will compete with other applications submitted for that cycle. If an application is unsuccessful, the applicant may subsequently submit one revised version of the application for review in a future cycle.

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The process leading to an award, including the business management review performed by the GMO, is described in Completing the Pre-Award Process below. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any NIH or HHS official or board.

2.5 Completing the Pre-Award Process

Following the peer review process, applications that an IC may fund are reviewed for a number of other considerations. These include, as applicable, alignment with NIH’s funding principles, review of the project budget, assessment of the applicant’s management systems, determination of applicant eligibility, and compliance with public policy requirements. The applicant may be asked to submit additional information (such as other support or verification of IACUC approval) or to undertake certain activities (such as negotiation of an F&A cost rate) in anticipation of an award. However, such requests by NIH do not guarantee that an award will be made. Following review of all applicable information, the IC will determine whether an award can be made, if special conditions are required, and what level of funding is appropriate.

Although these reviews and determinations occur before NIH makes a new award, grantees must continue to comply with eligibility and public policy requirements and maintain adequate management systems throughout the period of support. The pre-award process for non-competing continuation awards is a streamlined version of this process, including an assessment of progress (see Administrative Requirements—Monitoring—Reporting—Non-Competing Continuation Progress Reports).

2.5.1 Just-in-Time Procedures

NIH uses Just-in-Time procedures for certain programs and award mechanisms (each FOA will include specific guidance on the use). These procedures allow certain elements of an application to be submitted later in the application process, after review when the application is under consideration for funding. The standard application elements include other support information (both active and pending) for senior/key personnel; certification of IRB approval of the project’s proposed use of human subjects; verification of IACUC approval of the project’s proposed use of live vertebrate animals; and evidence of compliance with the education in the protection of human research participants requirement. Other program-specific information may also be requested using this procedure. (Applications in response to RFAs also may be subject to these procedures. The RFA will specify the timing and nature of required submissions.)

Applicants will be notified (primarily by e-mail) when Just-in-Time information is needed. This notification is not a Notice of Award nor should it be construed to be an indicator of possible funding. Applicants should only submit this information when requested. Information must be submitted electronically using the Just-in-Time feature in the eRA Commons. In some circumstances the GMO may ask for information in addition to the descriptions below, e.g., if the application involves hESCs and the applicant did not identified a hESC from the NIH Registry in the application.

The requirement for applicants to verify the accuracy and validity of all administrative, fiscal, and programmatic information extends to information submitted through the Just-in-Time process. Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up to the time of award. This includes items such as Other Support changes that could lead to budgetary overlap, scientific overlap, or commitment of effort greater than 12 person-months for the PD/PI(s) or any Senior/Key Personnel; or any changes in the use or approval of vertebrate animals or human subjects. Similar to the NIH public policy requirements, applicants are responsible for establishing and maintaining the necessary processes to monitor its compliance and informing NIH of any problems or concerns. Failure to address changes to Just-in-Time submissions prior to award does not diminish the applicant's responsibility to address changes post-award by submitting a prior approval request to NIH in accord with Administrative Requirements—Changes in Project and Budget—NIH Standard Terms of Award.

Other Support. Information on other active and pending support will be requested as part of the Just-in-Time procedures. Other support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes or gifts are not included. Other support is requested for all individuals designated in an application as senior/key personnel—those devoting measurable effort to a project. Information on Other Support is not specifically requested for Program Directors, training faculty, and other individuals involved in the oversight of training grants since applicable information is collected in other sections of a training grant application. It is also not requested for individuals categorized as Other Significant Contributors.

IC scientific program and grants management staff will review this information before award to ensure the following:

• Sufficient levels of effort are committed to the project.
• There is no scientific, budgetary, or commitment overlap.
  • Scientific overlap occurs when (1) substantially the same research is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific research objective and the research design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source.
  • Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.
  • Commitment overlap occurs when an individual’s time commitment exceeds 100 percent (i.e., 12 person months), whether or not salary support is requested in the application.
  • Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the IC with the applicant and the PD/PI at the time of award.
• Only funds necessary to the approved project are included in the award.

Certification of IRB Approval. If the proposed project involves human subjects research, the certification date of IRB review and approval must be submitted. Pending or out-of-date approvals are not acceptable. See Public Policy Requirements/Human Subjects for additional information.

Verification of IACUC Approval. If the proposed project involves research with live vertebrate animals, verification of the date of IACUC approval of those sections of the application that involve use of vertebrate animals along with any IACUC-imposed changes must be submitted. Pending or out-of-date approvals are not acceptable. See Public Policy Requirements/Animal Welfare for additional information.

Human Subjects Education Requirement. If the proposed project involves human subjects research, certification that any person identified as senior/key personnel involved in human subjects research has completed an education program in the protection of human subjects must be submitted. See Public Policy Requirements/Human Subjects/Education in the Protection of Human Research Participants for additional information.

Human Embryonic Stem Cells (hESCs). If the proposed project involves hESCs and the applicant did not identify a hESC line from the NIH Human Embryonic Stem Cell Registry in the application, the line(s) should be included in the Just-in-Time submission.

Other Information Requested by the Awarding IC. NIH IC’s may also request additional Just-in-Time information on a case-by-case basis, such as revised budgets or changes to the human subjects or vertebrate animal sections of the application.

2.5.2 Submitting Revised Project Summary/Abstracts, Specific Aims, and/or Public Health Relevance Statement

When requested by NIH as part of the pre-award process, PD/PIs and the AOR should discuss potential changes in scope with NIH PO and revise the Project Summary/Abstract, Specific Aims, and/or Public Health Relevance sections of their application as appropriate. Once all issues are resolved, applicants should e-mail a document with final versions of the revised sections to the IC-designated e-mail address (normally a Program Official, Grants Management Official, or centralized e-mail box) as a single Microsoft Word or PDF file. Be reminded that all revised application information submitted to the NIH must be approved by an AOR. Applicants should use the template found at: http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_ModifiedScopeTemplate.doc. The template includes specific headings that must be used for each section. All three headings must be included in the document that is submitted even if a particular section had no changes from the previous submission. If there are no changes for a section include the header but leave the text area blank to ensure appropriate processing of this information by NIH’s electronic systems.

2.5.3 Determining Applicant Organization Eligibility

All applicant organizations must complete the one-time eRA Commons registration process prior to submitting any application (paper or electronic) to the NIH. During the registration process, NIH may make a preliminary assessment of applicant organization eligibility. Applicants should be prepared to establish their eligibility to receive and administer all awards (that are applied for), and NIH reserves the right to deny registration if an organization is determined not to be an appropriate applicant for a particular FOA.

NIH awards may be made only to eligible applicants. Continued funding is dependent on the grantee’s continued eligibility. In general, domestic or foreign, public or private, non-profit or for-profit organizations and individuals are eligible to receive NIH grants. However, on the basis of statutory, regulatory, or published policy limitations, under certain programs or types of awards, NIH may limit eligibility to, or exclude from eligibility, classes or types of entities. Examples are limitations on the participation of foreign entities, and programs under which only small businesses are eligible applicants. The determination of eligibility includes verification of the applicant’s status. The applicant may be required to provide proof of its status by submitting documentation; otherwise the AOR’s signature on the application certifies that the applicant is eligible to apply for and receive an award (e.g., a small business applying under the SBIR or STTR programs).

In addition to reviewing organizational eligibility, NIH may consider other factors relating to the applicant’s ability to responsibly handle and account for Federal funds and to carry out the project. These factors include the applicant’s intended role in the project, the location where the project will be performed, the role of the PD/PI in the project, and the PD/PI’s employment and citizenship status. Although some of these same considerations are reviewed as part of the peer review, NIH’s concern at this stage in the process is making an award to a legal entity that will be accountable for both the performance of the approved project or activity and the appropriate expenditure of funds. NIH will not make an award to an applicant that does not have a substantive role in the project and would simply serve as a conduit for another entity.

2.5.4 Determining Eligibility of Individuals

It is the responsibility of the applicant organization to select the individuals who have the appropriate expertise to manage the scientific and administrative aspects of the project. The eligibility of these individuals to complete the project will be evaluated during peer review and at the IC level by grants management and program staff.

The GMO will verify whether the proposed PD/PI or other senior/key personnel are debarred or suspended from participation in Federal assistance programs (see Public Policy Requirements and Objectives—Debarment and Suspension for certification requirements).

Generally, PD/PIs and other personnel supported by NIH research grants are not required to hold any particular education degree, and are not required to be U.S. citizens. However, some NIH programs/mechanisms have a citizenship requirement. Any citizenship requirement will be stated in the FOA. In these cases, individuals are required to have the appropriate citizenship status when the award is made rather than when the application is submitted. For example, under most career development awards or Kirschstein-NRSA individual fellowships, the individual to be trained must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence at the time of award.

NIH requires the applicant to determine that individuals’ visas will allow them to remain in this country long enough for them to be productive on the research project, but NIH does not provide guidance on or assess the different types of visas. NIH expects grantee organizations to have policies, consistently applied regardless of the source of funds, to address this area. If a grant is awarded and an individual’s visa will not allow a long enough stay to be productive on the project, NIH may terminate the grant (see Administrative Requirements—Changes in Project and Budget and Administrative Requirements—Enforcement Actions—Suspension, Termination, and Withholding of Support).

The eligibility requirements for trainees and additional eligibility requirements for fellows are addressed in Ruth L. Kirschstein National Research Service Awards chapter in IIB.

In the post-award phase, NIH monitors changes in grantee and project status to ensure they meet legal and programmatic requirements and takes actions necessary to protect the Federal government’s interests.

2.5.5 Cost Analysis and Assessment of Management Systems

The GMO will ensure that a cost analysis is performed on any application that requires a detailed budget. Cost analysis involves obtaining cost breakdowns, validating cost data, evaluating specific elements of cost, and examining data to determine the necessity for, and the reasonableness and allowability of, the costs included in the application budget. The extent of cost analysis will depend on the type of funding instrument and award mechanism, the complexity of the project, prior experience with the applicant, and other factors. Information on the applicable cost principles and on allowable and unallowable costs under NIH grants is provided in the Cost Considerations chapter.

The amount of NIH funding is based on reasonable and allowable costs consistent with the principles of sound cost management, considering IC priorities (e.g., program relevance), constraints on the growth of average grant costs, and available funds.

In addition to considering the specific information provided in the application, the GMO determines the adequacy of the applicant’s financial and business management systems that will support the expenditure of and accountability for NIH funds. When an applicant has had no prior Federal grants or cost-reimbursement contracts, the GMO may review the applicant’s financial management and other management systems before award, or within a reasonable time after award, to determine their adequacy and acceptability. For an applicant with prior NIH or other Federal cost-reimbursement awards, the GMO may review recent audit reports and other available information to determine whether the applicant’s management systems meet the standards established in 45 CFR 74 or 45 CFR 92, as appropriate. The GMO will advise the applicant if additional information is required. On the basis of the review results, the GMO will determine the need for any corrective action and may impose special conditions on the award.