This glossary defines terms commonly used throughout this policy
statement. These definitions may be amplified and additional
definitions may be found in other sections of this document and
in source documents such as applicable statutes, grants administration
regulations, and OMB Circulars.
This glossary also includes a list of commonly used acronyms and
Application: A request for financial support of a project/activity
submitted to NIH on specified forms and in accordance with NIH
See "Application and Review Processes.")
for detailed information about the appliction process, including an
explanation of the types of applications.
Approved Budget: The financial expenditure plan for the
grant-supported project or activity, including revisions approved
by NIH as well as permissible revisions made by the grantee.
The approved budget consists of Federal (grant) funds and, if
required by the terms and conditions of the award, non-Federal
participation in the form of matching or cost sharing. The approved
budget specified in the initial Notice of Grant Award may be shown
in detailed budget categories or as total costs without a categorical
breakout. Expenditures charged to an approved budget that consists
of both Federal and non-Federal shares are deemed to be borne
by the grantee in the same proportion as the percentage of Federal/non-Federal
participation in the overall budget.
Authorized Institutional Official: The individual, named
by the applicant organization, who is authorized to act for the
applicant and to assume the obligations imposed by the Federal
laws, regulations, requirements, and conditions that apply to
grant applications or grant awards.
Award: The provision of funds by NIH, based on an approved
application and budget, to an organizational entity or an individual
to carry out an activity or project.
Awarding Office: The NIH Institute or Center responsible
for the award, administration, and monitoring of grant-supported
Budget Period: The interval of time (usually 12 months)
into which a project period is divided for budgetary and funding
Competitive Segment: The initial project period recommended
for support (up to 5 years) or each extension of a project period
resulting from the award of a competing continuation grant that
establishes a new competitive segment for the project.
Consortium Agreement: A collaborative
arrangement in support
of a research project in which some portion of the programmatic
activity is carried out through a formalized agreement between
the grantee and one or more other organizations that are separate
legal entities administratively independent of the grantee.
Contract Under a Grant: A written agreement
grantee and a third party to acquire routine goods or services.
Cooperative Agreement: A financial assistance mechanism
used when substantial Federal programmatic involvement with the
recipient during performance is anticipated by the NIH Institute
Cost Sharing: See "Matching or Cost
Direct Costs: Costs that can be specifically identified
with a particular project(s) or activity.
Equipment: An article of tangible nonexpendable
personal property that has a useful life of more than 1 year and an acquisition
cost per unit that equals or exceeds the lesser of the capitalization
threshold established by the organization or $5,000.
Expanded Authorities: The operating authorities provided
to grantees under certain research grant mechanisms that waive
the requirement for NIH prior approval for specified actions.
Expiration Date: The date signifying the end of the current
budget period, after which the grantee is not authorized to obligate
grant funds regardless of the ending date of the project period
or "completion date."
Facilities and Administrative Costs:
Costs that are incurred
by a grantee for common or joint objectives and that, therefore,
cannot be identified specifically with a particular project or
program. These costs were previously known as "indirect
costs," and, in most instances, will be referred to in this
document as "F&A costs."
Federal Demonstration Partnership: A cooperative initiative
among some Federal agencies, including NIH; select organizations
that receive Federal funding for research; and certain professional
associations. Its efforts include a variety of demonstration
projects intended to simplify and standardize Federal requirements
in order to increase research productivity and reduce administrative
Federal Institution: A Cabinet-level department or independent
agency of the executive branch of the Federal Government or any
component organization of such a department or agency.
Financial Assistance: Transfer by NIH of money or property
to an eligible entity to support or stimulate a public purpose
authorized by statute.
Foreign Organization: An organization located in a country
other than the United States and its territories that is subject
to the laws of that country, regardless of the citizenship of
the proposed principal investigator.
For-Profit Organization: An organization, institution,
corporation, or other legal entity that is organized or operated
for the profit or financial benefit of its shareholders
or other owners. Such organizations are also referred to as "commercial
Grant: A financial assistance mechanism providing money,
property, or both to an eligible entity to carry out an approved
project or activity. A grant is used whenever the NIH awarding
office anticipates no substantial programmatic involvement with
the recipient during performance of the financially assisted activities.
Grant-Supported Project/Activities: Those programmatic
activities specified or described in a grant application or in
a subsequent submission(s) that are approved by an NIH Institute
or Center for funding, regardless of whether Federal funding constitutes
all or only a portion of the financial support necessary to carry
Grantee: The organization or individual awarded a grant
or cooperative agreement by NIH that is responsible and accountable
for the use of the funds provided and for the performance of the
grant-supported project or activities. The grantee is the entire
legal entity even if a particular component is designated in the
award document. The grantee is legally responsible and accountable
to NIH for the performance and financial aspects of the grant-supported
project or activity.
Grants Management Officer (GMO): An NIH official responsible
for the business management aspects of grants and cooperative
agreements, including review, negotiation, award, and administration,
and for the interpretation of grants administration policies and
provisions. Only GMOs are authorized to obligate NIH to the expenditure
of funds and to make changes to approved projects on behalf of
NIH. Each NIH Institute and Center that awards grants has one
or more GMOs with responsibility for particular programs or awards.
Indirect Costs: See "Facilities and
Institute/Center (IC): The NIH organizational component
responsible for a particular grant program(s) or set of activities.
The designated GMO and Program Official for that program or set
of activities are employees of the IC. Use of the terms "NIH
IC" or "awarding office" throughout this document
to designate a point of contact for advice and interpretation
of grant requirements and establish the focal point for requesting
necessary prior approvals or changes in the terms and conditions
of award refers specifically to the IC Grants Management Officer.
International Organization: An organization that identifies
itself as international or intergovernmental, has membership from,
and represents the interests of, more than one country, without
regard to whether the headquarters of the organization and location
of the activity are inside or outside of the United States.
Key Personnel: Individuals who contribute in a substantive
way to the scientific development or execution of a project, whether
or not they receive compensation from the grant supporting that
project. The principal investigator is included in this category.
Matching or Cost Sharing: The value
of third-party in-kind
contributions and the portion of the costs of a federally assisted
project or program not borne by the Federal Government. Matching
or cost sharing may be required by law, regulation, or administrative
decision of an NIH Institute or Center. Costs used to satisfy
matching or cost sharing requirements are subject to the same
policies governing allowability as other costs under the approved
Misconduct in Science: Fabrication, falsification, plagiarism,
or other practices that seriously deviate from those commonly
accepted within the scientific community for proposing, conducting,
or reporting research. The term does not include honest error
or honest differences in interpretations or judgments of data.
Monitoring: A process whereby the programmatic and business
management performance aspects of a grant are reviewed by assessing
information gathered from various required reports, audits, site
visits, and other sources.
Notice of Grant Award: The legally binding document that
notifies the grantee and others that an award has been made, contains
or references all terms and conditions of the award, and documents
the obligation of Federal funds. The award notice may be in letter
format and may be issued electronically.
Organization: A generic term used to refer to an educational
institution or other entity, including an individual, that receives
and/or applies for an NIH grant or cooperative agreement.
Principal Investigator/Program Director/Project Director:
An individual designated by the grantee to direct the project
or activity being supported by the grant. He or she is responsible
and accountable to the grantee for the proper conduct of the project
Prior Approval: Written approval from the Institute or
Center Grants Management Officer required for specified postaward
changes in the approved project or budget. Such approval must
be obtained prior to undertaking the proposed activity or spending
Program: A coherent assembly of plans, project activities,
and supporting resources contained within an administrative framework,
the purpose of which is to implement an organization's mission
or some specific program-related aspect of that mission. For
purposes of this policy statement, "program" refers
to those NIH programs that carry out their mission through the
award of grants or cooperative agreements to other organizations.
Program Income: Gross income earned by a grantee that
is directly generated by the grant-supported project or activity
or earned as a result of the award.
Program Official: The NIH Institute or Center official
responsible for the programmatic, scientific and/or technical
aspects of a grant.
Project Period: The total time for which support of a
project has been programmatically approved. The total project
period is comprised of the initial competitive segment, any subsequent
competitive segment(s) resulting from a competing continuation
award(s), and noncompeting extensions.
Real Property: Land, including land improvements, structures,
and appurtenances, but not movable machinery and equipment.
Recipient: The organizational entity or individual receiving
a grant or cooperative agreement. See "Grantee."
Small Business Concern: A business that is independently
owned and operated and not dominant in its field of operation;
has its principal place of business in the United States and is
organized for profit; is at least 51 percent owned, or in the
case of a publicly owned business, at least 51 percent of its
voting stock is owned by U.S. citizens or lawfully admitted permanent
resident aliens; has, including its affiliates, not more than
500 employees; and meets other regulatory requirements established
by the Small Business Administration at 13 Code of Federal Regulations
(CFR) Part 121.
State Government: The government of: any State of the
United States, the District of Columbia, the Commonwealth of Puerto
Rico, any U.S. territory or possession, or any agency or instrumentality
of a State exclusive of local governments. For purposes of NIH
grants, federally recognized Indian tribal governments are generally considered
State governments. State institutions of higher education and
State hospitals are not considered State governments for purposes
of the Department of Health and Human Services' general administrative
requirements for grants and this policy statement.
Stipend: A payment made to an individual under a fellowship
or training grant in accordance with preestablished levels to
provide for the individual's living expenses during the period
of training. A stipend is not considered compensation for the
services expected of an employee.
Substantial Foreign Component: Under a grant to a domestic
institution, the performance of any significant element or segment
of the project outside of the United States, either by the grantee
or by a researcher employed by a foreign institution, with or
without grant funds.
Suspension: Temporary withdrawal of a grantee's authority
to obligate grant funds, pending either corrective action by the
grantee, as specified by NIH, or a decision by NIH to terminate
Termination: Permanent withdrawal by NIH of a grantee's
authority to obligate previously awarded grant funds before that
authority would otherwise expire, including the voluntary relinquishment
of that authority by the grantee.
Terms and Conditions of Award: All legal requirements
imposed on a grant by NIH, whether based on statute, regulation,
policy, or other document referenced in the grant award, or specified
by the grant award document itself. The Notice of Grant Award
may include both standard and special conditions that are considered
necessary to attain the grant's objectives, facilitate postaward
administration of the grant, conserve grant funds, or otherwise
protect the Federal Government's interests.
Total Project Costs: The total allowable costs (both direct
costs and facilities and administrative costs) incurred by the
grantee to carry out a grant-supported project or activity. Total
project costs include costs charged to the NIH grant and costs
borne by the grantee to satisfy a matching or cost sharing requirement.
Withholding of Support: A decision by NIH not to make
a noncompeting continuation award within the current competitive
Acronyms and Abbreviations
|CFR||Code of Federal Regulations
|CSR||Center for Scientific Review
|DCA||Division of Cost Allocation
|F&A||Facilities and Administrative (costs)
|FCTR||Federal Cash Transactions Report (SF-272)
|FDP||Federal Demonstration Partnership
|FSR||Financial Status Report (SF-269 or 269A)
|GMO||Grants Management Officer
|HHS||Department of Health and Human Services
|IC||Institute or Center
|NGA||Notice of Grant Award
|NIH||National Institutes of Health
|NIHGPS||National Institutes of Health Grants Policy Statement
|NRSA||National Research Service Award
|OER||Office of Extramural Research
|OFM||Office of Financial Management
|OIG||Office of the Inspector General
|OMB||Office of Management and Budget
|OPERA||Office of Policy for Extramural Research Administration
|OPRR||Office for Protection from Research Risks
|ORI||Office of Research Integrity
|PI||Principal Investigator/Program Director/Project Director
|PMS||Payment Management System
|RFA||Request for Applications
|SBIR||Small Business Innovation Research Program
|SNAP||Streamlined Noncompeting Award Process
|STTR||Small Business Technology Transfer Program
THE NATIONAL INSTITUTES OF HEALTH AS A GRANT-MAKING
This section provides information about how NIH is organized to
award and administer grants and describes its relationship to
other organizations both within the Department of Health and Human
Services (hereafter referred to as "HHS" or the "Department")
and external to HHS.
NIH is an organizational component of HHS, the mission of which
is to improve human health by increasing scientific knowledge
related to disease and health. 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
and other Federal departments and agencies.
NIH is organized into Institutes and Centers (ICs), each with
its own mission and functions, separate appropriations, and statutory
authorities. The ICs that award grants and their points of contact
are listed in Part IV. Although these ICs operate
under the same
general grant process and requirements, there may be differences
of which applicants and grantees need to be aware. This information
may be obtained from NIH staff. The policies and procedures generally
applicable to NIH grants are set forth in this NIH-wide policy
At the Departmental level, HHS develops, issues, and maintains
regulations that govern the HHS 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 (applicable to grants to institutions of
higher education, hospitals, and other non-profit organizations).
These regulations are codified at 45 Code of Federal Regulations
(CFR) Part 92 (Uniform Administrative Requirements for Grants
and Cooperative Agreements to State and Local Governments) and
45 CFR Part 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)2. They provide the standard framework
for the terms and conditions of NIH awards as specified in Part
Roles and Responsibilities
The relationship between NIH and its grantees involves those engaged
in the scientific or technical aspects of the work as well as
those responsible for a variety of support functions. 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 operations. Although these roles
and responsibilities are ones with which NIH grantees should already
be familiar, they assume increasing importance as NIH shifts to
a greater reliance on systems compliance and provides greater
decision-making authority to grantees.
The following subsections highlight the major functions and areas
of responsibility of Federal and grantee staff. 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 Government
and the grantee. The responsibilities of those NIH staff members
in the Center for Scientific Review (CSR) involved only in the
initial peer review process are described in
and Review Processes" section. The responsibilities of other
offices, such as the Office for Protection from Research Risks,
are described in Part II.
NIH AND HHS STAFF
Grants Management Officer: The Grants Management Officer
(GMO) whose name appears on the Notice of Grant Award 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 is an employee of the NIH IC that makes the award and
is responsible for the efforts of IC grants management specialists.
The GMO also works closely with his or her counterparts in other
NIH ICs and with the designated Program Official. 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 funds or to change the funding, duration, or other terms and
conditions of award.
Grants Management Specialist: The Grants Management Specialist
is an agent of the GMO and is assigned responsibility for the
day-to-day management of a portfolio of grants.
Program Official: The Program Official is the IC employee
responsible for the programmatic, scientific, and/or technical
aspects of assigned applications and grants. Program Officials'
responsibilities include, but are not limited to, development
of research and research training programs to meet the IC's mission;
coordination with CSR/IC Scientific Review Administrators; and
postaward administration, including review of progress reports,
participating in site visits, and other activities complementary
to those of the IC GMO. The Program Official and the GMO work
as a team in many of these activities.
Scientific Review Administrator: The Scientific Review
Administrator (SRA) is a health science administrator that manages
the activities of a scientific review group, including CSR study
sections. The SRA performs an initial review of 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 scientific review group meeting.
Other NIH and HHS Staff: The grantee may be required to
interact with other NIH or HHS staff/offices, in addition to the
IC GMO and Program Official, with respect to its organization-wide
systems and/or individual transaction(s). These include the office
responsible for negotiation of F&A costs and research patient
care rates, typically the cognizant (based on geographical location)
HHS Division of Cost Allocation office or the Office of Contracts
Management, NIH3; the Division of Payment Management; the Office
of the Inspector General; the Office for Protection from Research
Risks, and the Office of Research Integrity. Staff 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 IV
includes a list of these organizations and their addresses and
Authorized Institutional Official: This official 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 or changes in award terms and
conditions. In signing a grant application, this individual indicates
the applicant organization's intent to comply with all applicable
terms and conditions of award, including assurances and certifications
referenced in the application, and attests to the fact that the
administrative, fiscal, and scientific information in the application
is true and complete and in conformance with governing Federal
and organizational requirements. This individual's signature
on the grant application further assures 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. (See also "Legal
of Application".) This individual is also responsible to
NIH for ensuring that the organization complies with the terms
and conditions of individual awards and organization-wide requirements,
such as financial management and property management requirements.
NIH does not specify the organizational location or full set
of responsibilities for such an official; however, it requires
the designation of such an official as the focal point for the
organization's responsibilities as the grantee.
Principal Investigator: The principal investigator (PI)
(may also be known as "program director" or "project
director") is the individual, designated by the grantee,
responsible for the scientific or technical aspects of the grant
and day-to-day management of the project. The PI must have a
formal written appointment with the applicant organization, which
must be in the form of an official relationship between the parties,
but need not involve a salary or other form of remuneration.
The PI is a member of the grantee team responsible for ensuring
compliance with the financial and administrative aspects of the
award. He or she works closely with designated officials within
the grantee organization to create and maintain necessary documentation,
including both technical and administrative reports; prepare justifications;
ensure that Federal support of research findings is appropriately
acknowledged in publications, announcements, news programs, etc.
Availability of Research
Results: Publications and Intellectual Property, Including Unique
Research Resources"); and comply with organizational as well
as Federal requirements. NIH encourages the PI to maintain contact
with the NIH Program Official with respect to the scientific aspects
of the project. NIH also encourages the PI to maintain contact
with the IC GMO concerning the business and administrative aspects
of the award.
NOTE: The concept of co-principal investigators is not formally
recognized by NIH. NIH staff conduct official business only with
the designated PI and authorized institutional officials.
Application and Review Processes
This subsection provides an overview of the types of grants NIH funds;
the ways in which potential applicants can learn about funding
opportunities; distinctions among types of applications; application
requirements, restrictions, and deadlines; how applications are
reviewed and by whom; how results are communicated; and applicant
rights. It also lists publications and NIH Web sites that can
be accessed for additional information concerning the NIH grants
process and programs.
NIH ICs make grant awards 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). The applicability
of requirements may vary for different activity codes. Therefore,
applicants should consult one or more of the information sources
described at the end of this section to become knowledgeable about
the variety of NIH grant support available and specific application
requirements. Some of these distinctions are also significant
for purposes of applying Parts II and III of this policy statement.
In general, NIH grants may be awarded to organizations that are
domestic or foreign, public or private, and non-profit or for-profit.
Eligible organizations include governments, institutions of higher
education, hospitals, individuals and Federal institutions. Any
special criteria for applicant eligibility or requirements concerning
the qualifications of the principal investigator or other staff
will be specified in the program solicitation, program guidelines,
or other publicly available documents. Part III includes information
on trainee and fellow eligibility.
TYPES OF APPLICATIONS
The following describes the most frequently used types of applications
in the NIH grants process and the prefixes NIH uses to distinguish
them. With the exception of the "noncompeting continuation
application," all of the application types listed below are
considered "competing," since they must compete through
the peer review process for available funding with other applications
submitted. The process and requirements
for noncompeting applications
are specified in Part II.
- 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.
- Competing Continuation Application (Type 2): A request
for funding to renew, by one or more additional budget periods,
a project period that would otherwise expire.
- Competing Supplemental Application (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.
- Revised (Amended) Application: An unfunded application
that the applicant has modified following initial review and resubmitted
for consideration. NIH allows a maximum of two revised applications
in the 2-year period dating from submission of the original, unamended
- Noncompeting Continuation Application (Type 5): A
request for funding for the second or subsequent budget period
within an approved project period.
The preponderance of applications submitted to NIH under the categories
of research, and research training and fellowships are for investigator-initiated
research and are considered "unsolicited" applications.
NIH reviews such applications in three review cycles per year.
The schedules for submission, review, and award of competing
unsolicited applications are included in the application kit and
on the NIH Home Page. Applicants are encouraged to contact the
IC from which they plan to seek funding. See Part IV
for a list of the IC contact points.
Preliminary contact with the IC is required if an applicant
anticipates submitting a single unsolicited (investigator-initiated)
application, whether a new, competing continuation, competing
supplement, or amended grant application under any NIH support
mechanism, with a proposed direct cost budget of $500,000 or more
for any one year. This requirement also applies to a group of
applications, such as those for clinical trial networks, meeting
that threshold in the aggregate even if no single application
in the group requests that much. This contact should occur
as early in the application development process as possible.
Applicants that are uncertain about which IC to contact should
contact the Division of Receipt and Referral,
CSR (see Part IV).
CSR will accept such applications for review only if an IC has
agreed to accept the application for consideration and the applicant
submits a letter
to that effect, with the name of the authorizing IC official,
with its application (see "The Peer Review Process
below). An application subject to this policy that does not
include the required information in the cover letter accompanying
the application will be returned to the applicant without review.
This policy does not apply to applications submitted in response
to Requests for Applications (RFAs) (see below) but such
must be responsive to any budgetary limits stated in the relevant
RFA or NIH will return them to applicants without review.
NIH may develop areas of high priority or special research interest
and use a special solicitation to stimulate submission of applications
in those areas. These solicitations are published in the NIH
Guide for Grants and Contracts and take one of two forms.
NIH uses "program announcements" (PAs) to describe
new, continuing, or expanded program interests of an IC or to
announce the availability of a new mechanism of support. PAs
may be used for any support mechanism described above other than
construction awards. Unless otherwise specified in the PA, new
applications (and associated competing continuation and competing
supplemental applications) submitted in response to PAs are treated
as "unsolicited," are subject to the same receipt dates,
compete for funding with all other unsolicited applications, and
are subject to the standard peer review process. PAs are also
used for soliciting applications for programs such as the Small
Business Innovation Research (SBIR) and Small Business Technology
Transfer (STTR) programs, which issue announcements annually.
Those applications must be received by the date(s) specified
in the PAs.
A more targeted solicitation is the Request for Applications (RFA)
which may be used to solicit:
- Grant applications in a well-defined scientific area;
- Research grant applications for a one-time competition;
- Construction grant applications; or
- Applications for cooperative agreements.
RFAs are stand-alone solicitations, and each will provide sufficient
information to allow prospective applicants to determine whether
to apply, including the amount of funding available, the number
of awards anticipated, the deadline date for receipt of applications,
and other information describing the nature of the effort desired
and the obligations of recipients. For cooperative agreements,
the RFA will describe the responsibilities and obligations of
NIH and the awardee as well as joint responsibilities and obligations.
To be considered for support, an applicant must be an eligible
entity and must submit a complete application in accordance with
established receipt dates (i.e., deadlines). Information to be
submitted typically includes a project description, budget and
budget justification, biographical sketches of key personnel,
and other information specified in the application kit, in the
solicitation, 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. 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 must also demonstrate compliance (or intent to comply),
through certifications 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. Public policy
requirements and cost and administrative policies are detailed
in Part II.
The required application forms vary by support mechanism and by
the type of funding requested. The forms for competing
applications are specified in Table 1. The application requirements
for noncompeting awards are discussed in Part II.
These forms, other than those for the SBIR/STTR programs, are
included in application kits maintained by an organization's office
of sponsored research or business office. Application kits are
also available from the Office of
Extramural Outreach and Information
Resources, Office of Extramural Research, NIH, at (301) 435-0714,
e-mail at firstname.lastname@example.org, or mail at the address listed in
Part IV. Certain forms (rather than a complete application kit)
are available electronically on the
NIH Home Page.
NIH does not distribute software for computer generation of the
The SBIR/STTR applications are included in the SBIR and STTR Phase
I grant solicitations, which are available electronically on NIH's
Funding Opportunities" site on the NIH
A limited number of hard copies of the SBIR/STTR solicitations
is produced. Subject to availability, they may be obtained from
the PHS SBIR/STTR Solicitation Office, 13687 Baltimore Avenue,
Laurel, MD 20707-5096, telephone: (301) 206-9385, fax: (301) 206-9722,
or e-mail: email@example.com. Each SBIR and STTR Phase I grantee
(small business concern) is automatically sent a Phase II application
REQUIRED FORMS FOR COMPETING APPLICATIONS
|Application for a Public Health Service Grant
||New, revised, competing continuation, and competing supplemental research project grants and cooperative agreements (other than those under the SBIR and STTR programs), program projects, centers, career development awards, Institutional National Research Service Awards (training grants), and conference grants
|Application for Public Health Service Individual National Research Service Award
||Competing applications for fellowships
|Application for Public Health Service Individual National Research Service Award Continuation
||Continuation applications for fellowships
|Public Health Service Grant Application for Use by: State and Local Government Applicants and Nongovernmental Applicants for Health Services Projects
PHS-5161-1, including Standard Form (SF) 424, with budget and assurances applicable to non-construction (424-A and 424-B) or construction (424-C and 424-D)
||State, local, and Indian tribal government applicants for all types of grants, and nongovernmental applicants for construction grants
|Small Business Innovation Research (SBIR) Program Grant Applications
-- Phase I
|Small Business Technology Transfer (STTR) Program Grant Applications
|Competing applications|--Phase I
Application Receipt Points and Deadlines
All competing applications, whether solicited or unsolicited,
are required to be sent or delivered, in the number of copies
specified in the application kit or solicitation, to the central
NIH receipt point4. The address for that office is:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, MSC 7710
Bethesda, MD 20892-7710
Preaddressed mailing labels are included in application kits.
If express mail or courier service is used, the zip code should
be changed to 20817.
An unsolicited application will be considered to be on time for
a particular review cycle if it is received by or mailed on or
before the published receipt date for that cycle and a proof of
mailing is provided. If the receipt date falls on a weekend or
a holiday, the date for receipt/mailing is extended to the next
Under an RFA or a PA, if a solicitation-specific deadline date
is included, an application received after the deadline date may
be accepted only if it carries a legible proof-of-mailing date
assigned by the carrier and that date is no later than 1 week
prior to the deadline date.
The established receipt or deadline date will be waived only in
extenuating circumstances. A request for a waiver must accompany
the application and must explain the basis for requesting a waiver.
A waiver will not be considered prior to receipt of the application.
Legal Implication of Application
The signature of an authorized institutional official on the application
indicates the organization's intent to comply with the laws, regulations,
and policies to which a grant is subject, including applicable
public policy requirements (see "
Public Policy Requirements
and Objectives" in Part II). That official is also attesting
to the fact that the information contained in the application
is true and complete, and in conformance with Federal requirements
and the organization's own policies and requirements. Applicants
for and recipients of NIH grant funds, whether such funds are
received directly from NIH, indirectly under a contract or consortium
agreement, 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 Internal Revenue Service
(IRS). The applicant is also expected to be in compliance with
applicable State and local laws and ordinances.
Part II of this policy statement
includes administrative remedies
the Government may use in the event that a grantee or its employees
submit fraudulent information or do not comply with applicable
requirements. Even if a grant is not awarded, the applicant may
be subject to penalties if the information contained in an application,
including its assurances, is found to be false, fictitious, or
The Program Fraud and Civil Remedies Act of 1986, 31 United States
Code (U.S.C.) 3801, provides for the administrative imposition
by HHS of civil penalties and assessments against persons who
knowingly make false, fictitious, or misleading claims to the
Federal Government for money, including money representing grants,
loans, or benefits. A civil penalty of not more than $5,000 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 may be made in lieu of damages,
up to $150,000. Regulations at 45 CFR Part 79 specify the process
for imposing civil penalties and assessments, including hearing
and appeal rights.
The Criminal False Claims Act, 18 U.S.C. 287 and 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. Such person may be subject
to imprisonment of not more than 5 years and a fine.
The Civil False Claims Act, 31 U.S.C. 2739, 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
Government to get a false claim paid. A "false claim"
is any request or demand for money or property made to the United
States or to a contractor, grantee, or other recipient, if the
Government provides or will reimburse any portion of the funds
claimed. Civil penalties of $5,000 to $10,000 may be imposed
for each false claim, plus damages of up to three times the amount
of the false claim.
NIH may also administratively recover misspent grant funds pursuant
to the authorities contained in 45 CFR Parts 74 and 92.
Confidentiality of Information
Applicants are discouraged from submitting information considered
proprietary unless it is deemed essential for proper evaluation
of the application. However, if the application contains information
that the applicant organization considers to be trade secrets
or information that is commercial or financial, or privileged
or confidential, the pages containing that information should
be identified as specified in the instructions provided in the
PHS-398 application kit.
When information in the application constitutes trade secrets
or information that is commercial or financial, confidential or
privileged, it is furnished to the Government in confidence, with
the understanding that the information shall 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 Freedom of
Information and Privacy Acts,
which are discussed in "
Public Policy Requirements and Objectives"
in Part II. However, if a grant is awarded as a result of or
in connection with an application, the Government shall have the
right to use or disclose the information to the extent authorized
by law. This restriction does not limit the Government's right
to use the information if it is obtained without restriction from
THE PEER REVIEW PROCESS
Competing applications for NIH grants and cooperative agreements,
including those for competing continuations and competing supplements,
are subject to peer review as required by sections 406 and 492
of the PHS Act or by NIH policy. 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 and National Advisory Council/Board review. 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 the following
Web sites: http://www.csr.nih.gov
Information is also available by e-mail at DRGINFO@drgpo.drg.nih.gov
or firstname.lastname@example.org, or by
calling, writing, or faxing a
request to CSR (see Part IV).
The Center for Scientific Review 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 solicitation type, the support mechanism, and/or
the program. In general, CSR is responsible for the initial review
of research project grant applications (including Academic Research and
Enhancement Award (AREA) applications),
National Research Service Award (NRSA) fellowship applications,
and SBIR/STTR applications, while the ICs handle the initial review
of conference grant applications, applications resulting from
RFAs, and program project grant applications. However, CSR may
review other types of applications at IC request.
CSR Referral Officers, who are senior health science administrators
with both research and scientific review experience, assign each
application to an IC(s) for potential funding and to a scientific
review group 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/IC assignment.
Scientific review groups, including CSR study sections, are organized
by scientific discipline or current research areas and are managed
by health scientist administrators functioning as Scientific Review
Administrators. Generally, study sections are chartered groups
composed of formally appointed members serving multiyear terms,
to which the SRA often adds temporary members or other additional
reviewers. Special Emphasis Panels (SEPs) are formed on an ad
hoc basis 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.
Those individuals serving on a scientific review group, whether
a study section or SEP, are primarily scientists actively engaged
in research. NIH's conflict-of-interest and confidentiality of
information policies for reviewers are intended to ensure an unbiased
review process by minimizing even the appearance of a conflict
of interest and by restricting the use of privileged application
Within 6 to 8 weeks following the established application receipt
date, applicants are notified that the application has been received
and are advised of the SRA, scientific review group, and IC assignments.
At this time, applicants may request reconsideration of the review
group and IC assignment. Once the assignment process is completed,
the SRA is the contact for all communication with the applicant
until the conclusion of the review group meeting. An applicant
may withdraw an application from consideration at any time during
the review process. A request to withdraw an application must
be signed by the PI and an authorized institutional official.
If an application is withdrawn before it enters the review process,
CSR will return the application to the applicant. Applications
withdrawn by the applicant after the beginning of the formal review
may be destroyed by NIH or returned to the applicant at NIH's
In preparation for the initial review, SRAs review applications
to determine whether they are complete, conform to administrative
requirements, and contain the information necessary for a detailed
review. For each application, they then assign (from among the
standing and temporary members) reviewers to write a critique
of the application and readers to be prepared to discuss the application
in detail. NIH uses "just-in-time" procedures for certain
programs and award mechanisms that call for limited budget information
to be submitted with the application (i.e., a budget justification
and a modified biographical sketch) and for a possible NIH request
for additional information when the application is under consideration
for funding. (Applications in response to RFAs may also be subject
to these procedures. The RFA will specify the timing and nature
of required submissions.)
The goals of NIH-supported research are to advance the understanding
of biological systems, improve the control of disease, and enhance
health. Reviewers are asked to address, in their written comments,
the following aspects of the application in order to judge the
likelihood that the proposed research will have a substantial
impact on the pursuit of these goals. Each of these criteria
will be addressed and considered in assigning the overall score,
weighting them, as appropriate, for each application. An application
does not need to be strong in all categories to be judged likely
to have a major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out
work that, by its nature, is not innovative but is essential to
move a field forward.
- Significance: Does this study address an important problem?
If the aims of the application are achieved, how will scientific
knowledge be advanced? What will be the effect of these studies
on the concepts or methods that drive this field?
- Approach: Are the conceptual framework, design, methods,
and analyses adequately developed, well integrated, and appropriate
to the aims of the project? Does the applicant acknowledge potential
problem areas and consider alternative tactics?
- Innovation: Does the project employ novel concepts, approaches
or method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or technologies?
- Investigator: Is the investigator appropriately trained and
well suited to carry out this work? Is the work proposed appropriate
to the experience level of the PI and other researchers (if any)?
- Environment: Does the scientific environment in which the
work will be done contribute to the probability of success? Do
the proposed experiments take advantage of unique features of
the scientific environment or employ useful collaborative arrangements?
Is there evidence of institutional support?
While the review criteria are intended for use primarily with
unsolicited research project grant applications (e.g., R01s and
P01s), including those in response to PAs, to the extent reasonable,
they will also 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, as stated, may
not be feasible. Applications may also be reviewed against specific
criteria as stated in RFAs or PAs.
In addition to the above criteria, in accordance with NIH policy,
all applications will be reviewed with respect to the following:
- The adequacy of plans to include both genders, members of
minority groups, children, and their subgroups, as appropriate
for the scientific goals of the research. Plans for the recruitment
and retention of subjects will also be evaluated.
- The reasonableness of the proposed budget and duration in
relation to the proposed research.
- The adequacy of the proposed protection for humans, animals,
or the environment to the extent they may be adversely affected
by the project proposed in the application.
Following the initial review, the SRA prepares a summary statement
for each application 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 a priority score. Summary statements are
then provided to the IC's program staff and the PI.
Applicants responding to RFAs submit copies concurrently to CSR
and the soliciting IC. 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.
National Advisory Council or Board Review
For those applications recommended for further consideration,
the summary statements are presented to the assigned IC National
Advisory Council or Board (hereafter "Council") for
use in the second level of review. Council members include both
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 but also for relevance to the IC's programs and
priorities. The Council may concur with the initial review group'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 initial review
group for re-review. With very limited exception, an application
may not be considered for funding unless it has received a favorable
recommendation by both the initial review group and the Council.
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 seek reconsideration of the initial
review results if, after review of the summary statement, they
believe the review process was procedurally flawed (
for Grants and Contracts, Vol. 26, No. 38, November 21, 1997).
This appeal process is not intended to deal with differences
of scientific opinion between or among investigators and reviewers.
If the applicant has concerns about the conduct of the review,
whether the initial review was conducted by CSR or by the IC,
the applicant should discuss them with the program administrator
responsible for the application, who will attempt to resolve the
applicant's concerns. If, after discussion with the program administrator,
the investigator still has concerns, he or she may submit a formal
letter of appeal to the program administrator, who will handle
it in accordance with specific appeal procedures.
The program administrator will consult with the SRA or staff of
the IC scientific review office. This consultation may result
in a decision to re-review the application. A re-review consists
of a review of the same application, not a revised version, by
the same or another review group without access to the summary
statement of the disputed review. If NIH staff and the investigator
cannot agree on a course of action, the appeal will be reviewed
by the designated IC Appeals Officer. That official will make
the appeal letter available to the Council along with the IC recommendation
on the appeal and any written comments from the SRA or review
group. The Council may either reject the appeal and let the initial
review stand or recommend that the application be re-reviewed.
The Council's decision may not be further appealed.
Disposition of Applications
All incomplete applications and those applications determined
to be non-responsive to solicitation requirements will be returned
to the applicant by CSR or by the IC referral office without further
action. For unsolicited applications that are returned, the applicant
may resubmit a complete version of the application for consideration
in the next review cycle.
Following the initial review, the PI will receive a copy of the
summary statement and will be advised by letter from the responsible
IC whether the application has been recommended for further consideration
by the Council.
The IC Director or designee is the official that 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 an additional cycle(s) and will compete
with other applications submitted for that cycle. If an application
is unsuccessful, the applicant may subsequently submit up to two
revised versions of the application for review in a future cycle(s),
but NIH will not accept a revised application submitted more than
2 years from the receipt of the original application.
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 IC GMO, is described in
Part II. The
decision not to award a grant, or to award a grant at a particular
funding level, is discretionary and is not subject to appeals
to any NIH or HHS official or board.
Sources of Information
about NIH's Grants Process and Programs
As described below, NIH maintains a number of information resources
about its grant programs and activities that can be accessed through
the Home Page maintained by the Office of Extramural Research.
Some are descriptive materials that allow interested parties
to learn about NIH grant initiatives, funding opportunities, and
proposed and actual policy changes. Others provide historical
data. These documents are updated annually or as needed. The
NIH Web site address for these materials and other grant-related
http://grants.nih.gov/grants/oer.htm (a more
specific address may be provided below). In addition, these materials
may be requested using e-mail through
email@example.com, by telephone
at (301) 435-0714, or by writing to the Office of Extramural Outreach
and Information Resources, Office of Extramural Research, 6701
Rockledge Drive, Suite 6095, Bethesda, MD 20892-7910.
NIH Extramural Programs: a compendium of
the scientific programs of the NIH components that award grants,
cooperative agreements, and contracts. It indicates current areas
of research emphasis, highlights special interests of each IC,
and identifies specific NIH offices to be contacted for further
information about particular programs, policies, and procedures.
The Web site address is
NIH Guide for Grants and Contracts:
new programs and policies, including program announcements, Requests
for Applications, and Requests for Proposals. The Web site address
for the NIH Guide is
Research Grants and Contracts: annual listing
of extramural awards, previously known as "the brown book."
The Web site address is
Computer Retrieval of Information
on Scientific Projects (CRISP):
an on-line system,
updated quarterly, that provides a brief description of and administrative
data on each NIH-funded research project.
Program Guidelines: detailed policy and procedural information
applicable to specific programs/activities. NIH-wide program
guidelines are published initially in the NIH Guide for Grants
and Contracts (see above) and are also
IC Home Pages should also be consulted for IC-specific guidelines
(see Part IV).
Other documents providing information about or general descriptions
of NIH programs may also be requested. These include Helpful
Hints on Preparing a Research Grant Application to the NIH, Helpful
Hints on Preparing a Fellowship Application to the NIH, Research
Training and Career Development Programs, and NIH Minority
Programs. These documents contain useful information but
are not currently available on-line and may not provide as up-to-date
or complete information as those documents linked to the NIH OER
Each IC also maintains its own Home Page accessible through the
NIH Home Page submenu entitled "Institutes and Offices"
(see Part IV for current Web site addresses).