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
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.
188.8.131.52 eRA Commons Registration for the Organization
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
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.
184.108.40.206 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
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.
220.127.116.11 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.
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
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
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
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
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
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.
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.
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
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.
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.
18.104.22.168 Acceptance for Review of Unsolicited Applications Requesting $500,000 or More in Direct
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
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
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.
22.214.171.124 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:
Applications that were originally submitted in response to an RFA and now submitted as an investigator-initiated
Applications that were originally submitted
as investigator-initiated applications and subsequently submitted in response
to an RFA.
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.
126.96.36.199 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
188.8.131.52 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.
184.108.40.206 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.
220.127.116.11 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
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
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.
18.104.22.168 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
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).
Exhibit 3. Required Forms for Competing Applications
SF424 (R&R) Application
Guide for NIH and Other PHS Agencies
The SF424 (R&R) form
set, combined with a PHS Fellowship Supplemental form component, is used for
electronic submission of individual fellowship applications. The Fellowship
Supplemental form component is from the PHS 416-1.
Form PHS 398 is used for paper submission for those programs that have not yet transitioned to
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
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.
22.214.171.124 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
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.
126.96.36.199 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)
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.
188.8.131.52 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.
Essentially identical applications will not be reviewed except for: 1) individuals submitting an application for an Independent Scientist Award (K02) proposing essentially identical research in an application for an individual research project; and 2) individuals submitting an individual research project identical to a subproject that is part of a program project or center grant application.
2.3.10 Fraud, Waste and Abuse of NIH Grant Funds
Any individual who becomes aware of the existence (or
apparent existence) of fraud, waste, or abuse related to NIH grants or grant
funds should consider contacting:
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,
In addition, allegations of criminal offenses should be
reported to the Department of Health and Human Services, OIG
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 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
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,
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
184.108.40.206 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
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
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
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.
220.127.116.11.1 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
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.
18.104.22.168.2 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
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
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).
22.214.171.124.3 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.
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
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.
126.96.36.199 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.
188.8.131.52 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
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?
184.108.40.206 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
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
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.
220.127.116.11 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.
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
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
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.
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
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
IC scientific program and grants
management staff will review this information before award to ensure the
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
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
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
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
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.
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
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
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.
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.
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.