For a complete list of acronyms only, go to Acronym
A B C D E F G H I J K L M N O P R S T U V W X
- A - AA
Academic Research Enhancement Award (AREA - R15)
Grant award stimulating research at health professional academic institutions with not more than $6 million per year of NIH support in total costs in each of four or more of the last seven years. Go to AREA
Related to electronic submission of applications, the Accession number is the Agency tracking number provided for the application after Agency validations.
Account Administrator (AA)
As used by the eRA Commons
, a personal account an individual uses to log into the eRA Commons which is identified by a unique combination of username and password.
An individual typically in the grantee organization's central research administration office designated by a SO to facilitate the administration of NIH eRA Commons
accounts. The AA can create, modify and/or remove the necessary accounts for these types: AO, AA, FSR, PI or ASST. Although the AA can create additional accounts, the AA cannot modify institutional profile (IPF) information.
Obtaining supplies or services by the federal government with appropriated funds through purchase or lease. See Contract
A grant meeting the following criteria:
Today's date is between the budget start and end dates.
The grant has an eRA System (IMPAC II) application status code of "Awarded. Non-fellowships only." or "Awarded. Fellowships only."
A 3-character code used to identify a specific category of extramural research activity, applied to various funding mechanisms. NIH uses three funding mechanisms for extramural research awards: grants, cooperative agreements and contracts. Within each funding mechanism
, NIH uses 3-character activity codes (e.g., F32, K08, P01, R01, T32, etc.) to differentiate the wide variety of research-related programs NIH supports. A comprehensive list of activity codes
may be found on the Types of Grant Programs
Expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health.
The NIH Institute or Center (IC) to which the Center for Scientific Review (CSR) routes NIH grant applications for a funding decision. An IC may request to change this assignment if the application is more suited to another IC. Also referred to as primary assignment.
Administrative Official (AO)
In the eRA Commons
, reviews the grant application for accuracy before the signing official submits the final application to the NIH.
May be the same person as the signing official.
Resides in either the central research administration office or academic departments.
Create additional AO and PI accounts
Not authorized to transmit applications to the NIH.
Has authority to review electronically submitted application before it moves on to CSR.
The general business management practices that are common to the administration of all grants, such as financial accountability, reporting, equipment management, and retention of records. Uniform administrative requirements for grants are found in OMB Circular A-102 and OMB Circular A-110 (now found at 2 CFR Part 215
A request for (or the award of) additional funds during a current project period to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.
Automated Data Processing
Agency Data Integration Application (Manage Agency Data)
Allows Operating Divisions (OpDivs) to manage data in the IMPAC II system, including the ability to add, modify and retrieve Common Accounting Numbers (CAN) and Award Authorization data.
Alien Registration - Card
Alteration and Renovation (A&R)
A cost incurred by a recipient that is: (1) reasonable for the performance of the award; (2) allocable; (3) in conformance with any limitations or exclusions set forth in the Federal cost principles applicable to the organization incurring the cost or in the NoA as to the type or amount of cost; (4) consistent with regulations, policies, and procedures of the recipient that are applied uniformly to both federally supported and other activities of the organization; (5) accorded consistent treatment as a direct or indirect cost; (6) determined in accordance with generally accepted accounting principles; and (7) not included as a cost in any other federally supported award (unless specifically authorized by statute). For additional information on each, see Chapter 7.2 of the NIHGPS.
Changes the interior arrangements or other physical characteristics of an existing facility or of installed equipment so that it can be used more effectively for its currently designated purpose or adapted to an alternative use to meet a programmatic requirement. Major A&R (including modernization, remodeling, or improvement) of an existing building is permitted under an NIH grant only when the authorizing statute for the program specifically allows that activity.
Amendment (amended or revised applications)
Animal Welfare Assurance
Animals in Research
Annual Payback Activities Certification (APAC)
Document an institution and all performance sites involving animals in research must have on file with the Office of Laboratory Animal Welfare
before a PHS
Agency may award a grant or contract.
Annual Payback Activities Certifications (APACs) for PHS 6031-1 are notices used by Kirschstein-NRSA recipients to report on their payback activities annually, until their payback obligation is fulfilled.
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).
Applicable Clinical Trial
Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of trials that may be subject to the registration and reporting requirements in FDAAA. Applicable clinical trials generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S., involves a drug, biologic, or device that is manufactured in the U.S. (or its territories), or is conducted under an investigational new drug application (IND). For the complete statutory definition and more detailed information see http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm
Organization or person who actively applies but has not yet been awarded a grant.
A request for financial support of a project or activity submitted to NIH on specified forms and in accordance with NIH instructions. [For detailed information about the application process (including an explanation of the types of applications), go to Application Information and Processes
Application Identification Numbers
NIH accepts applications for most programs in three cycles. The applications received within a cycle are typically reviewed within the same council round. Many NIH Funding Opportunity Announcements are open for up to three years with standard due dates falling in each cycle.
Application Submission System & Interface for Submission Tracking (ASSIST)
The application number identifies:
Sample Application Identification Number
type of application (1)
activity code (R01)
organization to which it is assigned (AI)
serial number assigned by the Center for Scientific Review (CSR) (183723),
suffix showing the support year for the grant (-01)
other information identifying a supplement (S1), resubmission (A1), or a fellowship's institutional allowance. For contracts, the suffix is replaced by a modification number.
1 R01 AI 183723 -01 A1 S1
The Application Submission System & Interface for Submission Tracking (ASSIST) is a web-based system used to prepare multi-project (also known as multi-component or complex) grant applications using the SF424 Research & Related form set and to submit electronically through Grants.gov to NIH and other participating agencies. See ASSIST FAQs.
Application Viewing Window
Renewal (a.k.a. Competing continuation)
Competing Revision/Administrative Supplement Application for additional (supplemental) support to cover increased costs (non-competing administrative supplement) or to expand the scope of work (competing revision)
Extension- Request for additional years of support beyond the years previously awarded. Used only for select programs.
Change of grantee institution
Change of NIH awarding IC for a non-competing record
Change of NIH awarding IC for a Renewal application
Amended - See Resubmission
Contract types - See Contract Transaction Types
Once an error-free application is submitted through Grants.gov to eRA, the eRA system assembles an application image and posts it in the PD/PI's Commons account. The PD/PI, any delegated Assistants, and the Signing Official (SO) have 2 business days to view the assembled application in Commons - just as a reviewer would see it. The application viewing window is linked to the time of submission (i.e., begins the day after the assembled application image is posted in Commons).
Within the viewing window, the SO can Reject the application and stop it from moving further in the process. After the viewing window, the application automatically moves forward for further consideration and the submission process is complete.
The statute that provides the authority for Federal agencies to incur obligations to and make payments out of the U.S. treasury for specified purposes.
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 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.
The award of money, property, or services to a recipient to accomplish a public purpose as authorized by Federal statute. Assistance relationships (e.g., grants) are expressed in less detail than are acquisition relationships (contracts), and responsibilities for ensuring performance rest largely with the recipient or are shared with the Government.
Assistant Role (ASST)
In the NIH Commons
the role designed to allow PIs to delegate certain responsibilities for data entry of grant information and upkeep of their personal profiles. The ASST does not have any other functions in the system.
A certification by an applicant, normally included with the application or State plan, indicating that the entity is in compliance with, or that it will abide by, a particular requirement if awarded a Federal grant.
Authorized Organization Representative (AOR)
Average Programmatic Reduction
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. This official is equivalent to the Signing Official in the eRA Commons, i.e., holds the SO Role.
Submitting the grant on behalf of the company, organization, institution, or Government.
Signing grant applications and the required certifications and/or assurances necessary to fulfill the requirements of the application process.
The dollar amount a grant award is reduced from the amount recommended by the study section (scientific review group). This is done so Institutes can maintain a sufficient number of grants in their portfolio and to combat inflation of grant costs.
The provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.
Awarded Direct Costs
Awarded Indirect Costs
Awarded Total Costs
The NIH Institute or Center responsible for the award, administration, and monitoring of grant supported activities.
- B - Bayh-Dole Act
The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212), implemented by 37 CFR 401, affords grantees the right to elect title and retain ownership to inventions they develop with funding under an NIH grant award. Under the regulations, grantees are required to report all subject inventions to the awarding agency, as well as include an acknowledgement of federal support in any patents.
Best and Final Offer (BAFO)
A general science agreement between the U.S. and a foreign country. Grant applications from institutions in these countries that have been recommended for approval by the scientific review group are given special funding consideration by Council.
The focus of bioengineering issues at the NIH which consists of senior-level representatives from each of the NIH Institutes, Centers, and Divisions plus representatives of other Federal Agencies concerned with biomedical research and development. Go to Bioengineering Consortium (BECON).
Biomedical Research and Development Price Index (BRDPI)
Measures real annual changes in the prices of items and services required for research and development (R&D) activities.
Bridge awards provide continued but limited interim support (bridge funding) for meritorious investigators who just miss the funding cutoff and have minimal support from other sources. The continued funding will permit the PD/PI additional time to strengthen a resubmission application. A Bridge award recipient usually will receive an R56 award for a single year. Investigators may not apply for R56 grants. Applications for conversion to an R56 will be selected by IC staff from reviewed applications that fall at or near the payline margins.
Identifies the sub-mechanism category of the award for reporting purposes.
The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes.
- C - CA
Career Development Awards (CDA, K Series)
The cost of an asset (land, building, equipment), including the cost to put it in place. A capital expenditure for equipment includes the net invoice price and the cost of any modifications, attachments, accessories, or auxiliary apparatus to make it usable for the purpose for which it was acquired. Other charges, such as taxes, in-transit insurance, freight, and installation, may be included in capital expenditure costs in accordance with the recipient's regular accounting practices consistently applied regardless of the source of funds. Go to Section 184.108.40.206 Capital Expenditures
of the NIH GPS.
Awards for candidates who wish to further develop their careers in biomedical, behavioral and clinical research. Applicants are generally required to hold a research or health–professional doctoral degree or its equivalent; eligibility for some CDAs is limited to only applicants with health professional doctoral degrees. See Career Development Awards.
Unobligated Federal funds remaining at the end of any budget period that, with the approval of the GMO or under an automatic authority, may be carried forward to another budget period to cover allowable costs of that budget period (whether as an offset or additional authorization). Obligated, but unliquidated, funds are not considered carryover.
Catalog of Federal Domestic Assistance (CFDA)
Center for Scientific Review (CSR)
A database which helps the Federal Government track all programs it has domestically funded. Federal programs are assigned a number in the Catalog of Federal Domestic Assistance
(CFDA) which is referred to as the "CFDA number."
The NIH component responsible for the receipt and referral of grant applications to the PHS, as well as the initial review for scientific merit of most applications submitted to the NIH.
Center grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They support long-term, multi-disciplinary programs of research and development.
Central Contractor Registration (CCR) Database
Change in Scope
Chartered Advisory Committee
An activity whereby the objectives or specific aims identified in the approved grant application are significantly changed by the grantee after award. GMO prior approval is required for a change in scope to be allowable under an award. See Section 220.127.116.11 Change in Scope
in the NIH GPS for additional information.
Any committee formed for advisory purposes composed not wholly of Federal officials. Under the Federal Advisory Committee Act, standing committees must be chartered, i.e., approved by their parent Agency in collaboration with the U.S. General Services Administration to ensure a properly balanced representation (geographical, women, minorities) and meet other legal requirements
Chief Grants Management Officer
The Grants Management Officer within an awarding agency who is the principal Grants Officer in the agency. The Chief Grants Management Officer (CGMO) provides leadership to an organizational component that is responsible for the business and fiscal management of an IC's 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.
The NIH Policy on Inclusion of Children defines a child as an individual under the age of 21 years. The intent of the NIH policy is to provide the opportunity for children to participate in research studies when there is a sound scientific rationale for including them, and their participation benefits children and is appropriate under existing Federal guidelines. Thus, children must be included in NIH conducted or supported clinical research unless there are scientific or ethical reasons not to include them.
DHHS Regulations (45 CFR part 46, Subpart D, Sec.401-409) provide additional protections for children involved as subjects in research, based on this definition: "Children are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted." Generally, state laws define what constitutes a â€œchild.â€? Consequently, the age at which a child's own consent is required and sufficient to participate in research will vary according to state law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.
Research with human subjects that is:
Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes:
mechanisms of human disease
development of new technologies
Epidemiological and behavioral studies.
Outcomes research and health services research.
Studies falling under 45 CFR part 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.
Close Date or Closing Date
A research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5
Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:
Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.
Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
NIH-Defined Phase III Clinical Trial. An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
1See Common Rule definition of research at 45 CFR 46.102(d).
2See Common Rule definition of human subject at 45 CFR 46.102(f).
3The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
4An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects' biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
The process by which a Federal awarding agency determines that all applicable administrative actions and all required work under an award have been completed by the grantee and the Federal awarding agency. (See Section 8.6 Closeout
in the NIHGPS.)
Funding arrangement through which two or more Institutes or Centers share in the funding of a grant.
An individual involved with the PD/PI in the scientific development or execution of a project. The co-investigator (collaborator) may be employed by, or be affiliated with, the applicant/grantee organization or another organization participating in the project under a consortium agreement. A co-investigator typically devotes a specified percentage of time to the project and is considered senior/key personnel. The designation of a co-investigator, if applicable, does not affect the PD/PI's roles and responsibilities as specified in the NIH Grants Policy Statement (NIH GPS), nor is it a role implying multiple PD/PI.
Code of Federal Regulations (CFR)
The codified regulations of the Federal government based on the final agency regulations published in the Federal Register.
See Council on Financial Assistance Reform
The Federal agency which, on behalf of all Federal agencies, is responsible for: reviewing, negotiating, and approving cost allocation plans, indirect cost rate and similar rates; monitoring non-Federal audit reports; conducting Federal audits as necessary; and resolving cross-cutting audit findings. The cognizant agency under the applicable cost principles and under OMB Circular A-133 may be different for a given recipient.
Funds used for non-competing (type 5 or ongoing awards), typically 70-80 percent of the dollars spent for research project grants.
Committee Management Officer (CMO)
NIH CMO: The NIH Committee Management Officer is responsible for managing the implementation of the Federal Advisory Committee Act. The NIH CMO is responsible for developing and managing all committee management policy and procedure development for dissemination to all NIH IC staff as well as to Federal advisory committee members. The CMO reviews and finalizes all advisory committee charters and nomination slates for approval by the Secretary, DHHS or the Director, NIH and insures an accurate presentation of NIH committee activity on a public website managed by the General Services Administration.
I/C CMO: Each IC has a CMO or uses the resources of a service center to support the committee management function within the Institute or Center. The IC CMO is responsible for developing charters for committees, preparing nomination and appointment documents for membership to committees, providing technical assistance to committee members, providing initial review of conflict of interest disclosures and other responsibilities.
The NIH Common Fund supports cross-cutting, trans-NIH programs, including those referred to as NIH Roadmap programs. See The NIH Common Fund
New or renewal applications that must undergo initial peer review.
Competing Research Project Grant
An application for a Research Project Grant requiring competitive peer review. Also, a number of obligations which serve as an input for determining success rates.
A contracting term denoting a group of proposals considered acceptable by the initial peer review group which are potential candidates for an award.
A request for (or the award of) additional funds during a current project period to support new or additional activities which are not identified in the current award that reflect an expansion of the scope of the grant-approved activities. Competitive revisions require peer review.
The initial project period recommended for support (in general, up to 5 years) or each extension of a project period resulting from a renewal award.
For the purposes of applications and progress reports, a component is a distinct, reviewable part of a multi-project grant application or progress report for which there is a business need to gather detailed information identified in the funding opportunity announcement (FOA).
- Components must include defined work, personnel, performance sites, budget and general information (component organization, project period, project title, etc.).
- Components may also be referred to as "cores" or "projects." The FOA defines the construction and naming convention for the application; the funded grant defines the construction and naming convention for the progress report.
Note: For Research Performance Progress Report (RPPR) Question G.9, the term "foreign component" is distinct from "component" as defined here. However, a foreign component may also be a component in the RPPR.
A 'component type' is a named, agency-defined collection of forms that may be repeated within a multi-project grant application.
For example, a specific multi-project application includes one Administrative Core, two Core and three Project components. In this example, the application includes 6 components using three different component types (Administrative Core, Core, Project).
'Overall' is a special component type, used by the applicant organization, with a single occurrence in every multi-project grant application. The Overall component typically contains information about the application as a whole and how the various other components fit together.
The earliest planning stage of an initiative [request for applications (RFA), request for proposals (RFP), or program announcement (PA)]. Concepts are brought before the Advisory Council for concept clearance. Not all concepts cleared by Council are published as initiatives depending on the availability of funds.
Conference (domestic or international)
A symposium, seminar, workshop, or any other organized and formal meeting, whether conducted face-to-face or via the Internet, where individuals assemble (or meet virtually) to exchange information and views or explore or clarify a defined subject, problem, or area of knowledge, whether or not a published report results from such meeting.
Conflict of Interest
Conflict of Interest is a cross-cutting issue that affects many policy areas such as peer review, financial conflict of interest, and responsible conduct of research. There are different uses of this term throughout this document. It generally means that a competing personal interest could affect, or could appear to affect, an individual's judgment or could cause the individual's impartiality to be questioned. Conflicts of Interest (actual or potential) may arise in the objective review process or in other activities or phases of the financial assistance process. See also Financial Conflict of Interest
for a specific definition covering that policy area.
A territorial division of a state from which a member of the United States House of Representatives is elected.
A formalized agreement whereby a research project is carried out by the grantee and one or more other organizations that are separate legal entities. Under the agreement, the grantee must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. These agreements typically involve a specific level of effort from the consortium organization's PD/PI and a categorical breakdown of costs, such as personnel, supplies, and other allowable expenses, including F&A costs. The relationship between the recipient and the collaborating organizations is considered a relationship. Go to Chapter 15 Consortium Agreements
in the NIHGPS.
Dollar amounts adjusted for inflation, based on buying power in a selected base year. The BRDPI is used to determine constant dollars from current dollars.
Construction of new buildings or the modernization of, or completion of shell space in, existing buildings (including the installation of fixed equipment, but excluding the cost of land acquisition and off-site improvements). The construction of shell space is not allowable as a construction activity since shell space does not provide usable space for research activities. Expansion, new construction, or activities that would change the "footprint" of an existing facility (e.g., relocation of existing exterior walls, roofs, or floors, attachment of fire escapes) is considered construction. See Chapter10 Construction
in the NIHGPS
Consumer Price Index (CPI)
An individual who provides professional advice or services for a fee, but normally not as an employee of the engaging party. In unusual situations, an individual may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. To prevent apparent or actual conflicts of interest, grantees and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants also include firms that provide professional advice or services. (See Cost Considerations-Allowability of Costs/Activities-Selected Items of Cost-Consultant Services
Measurement of changes in prices of a broad range of consumer items.
When multiple PD/PIs are designated, NIH requires that the applicant organization identify one of the PD/PIs as the Contact PD/PI to serve as a primary point of contact. 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. 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. See Chapter 9 Multiple PD/PI
in the NIHGPS.
As a way of recognizing their service to NIH, reviewers with substantial review service are permitted to submit their research grant applications (R01, R21, or R34) on a continuous basis and to have those applications undergo initial peer review in a timely manner. Read more about Continuous Submission
An award instrument used to acquire from a non-federal party, by purchase, lease, or barter, property or services for the direct benefit or use of the Federal government. The same term may be used to describe a vendor relationship between a recipient and another party under a grant (to acquire routine goods and services); however, the recipient may use subaward to describe the contract under a grant relationship.
Contract Transaction Types
Continuation of an incrementally (typically, in one year increments) funded contract
Task orders and subsequent modifications relating to existing ordering agreements
Exercise of option
Government employee authorized to execute contractual agreements on behalf of the Government.
Cooperative Agreement (U Series)
A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Cooperative Research and Development Agreement (CRADA)
Any agreement between one or more NIH laboratories and one or more non-Federal parties under which the PHS, through its laboratories, provides personnel, services, facilities, equipment, or other resources with or without reimbursement (but not funds to non-Federal parties) and the non-Federal parties provide funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory.
Any amount charged in excess of the Federal share of costs for the project period (competitive segment).
Council on Financial Assistance Reform (COFAR)
The Council on Financial Assistance Reform (COFAR) is an interagency group of representatives from the eight largest grant-making agencies established to create a more streamlined and accountable structure to coordinate financial assistance. The COFAR works with Congress, Federal agencies, state, local and tribal governments, institutions of higher education, nonprofit organization, Federal Councils and other groups to improve Federal financial management. Established in October 2011, the COFAR is leading several efforts to improve delivery, management, coordination, and accountability of Federal grants and cooperative agreements, which includes the development of the uniform guidance. For more information, visit https://cfo.gov/cofar/.
At the NIH, there are at least three, and sometimes four, council rounds each fiscal year: October, January, May, and sometimes August. Application receipt dates, initial review dates, and council review dates all fall within one of these council rounds. Incoming grant applications all are assigned to a council round.
National Advisory Council or Board, mandated by statute, providing the second level of review for grant applications for each Institute/Center awarding grants. The Councils/Boards are comprised of both scientific and lay representatives. Council/Board recommendations are based on scientific merit (as judged by the initial review groups) and the relevance of the proposed study to an institute's programs and priorities. With some exceptions, grants cannot be awarded without recommendations for approval by a Council/Board.
Unless noted, the total number of grants shown, excluding administrative supplements.
Credential is a field on Grants.gov's R&R Senior/Key Person Profile form which is part of every competing grant application submitted through Grants.gov to NIH. Including the eRA Commons ID for the PD/PI, any multi-PD/PIs and Project Leads (for multi-project application components) is an NIH requirement and is critical to our ability to post errors, warnings and the assembled application image in eRA Commons. The credential field is not marked required on the federal-wide form since not all agencies that use the form need this field. NIH uses the Health and Human Services logo within the application guide
to flag agency-specific instructions and clarifications for fields on federal-wide forms. Pay special attention to the HHS logo or you may miss key NIH requirements.
Cumulative Inclusion Enrollment Report
An overall evaluation of a grant application prepared by a reviewer before an initial peer review meeting and presented to a Scientific Review Group
at the meeting.
The Cumulative Inclusion Enrollment Report is used to report the sex/gender, race, and ethnicity of the actual participants that have been enrolled in the study or if an applicant is proposing a new study using an existing dataset/resource where the participants have already been enrolled.
For more details about completing these forms, please see the Supplemental Instruction Guide
Actual dollars awarded, without adjustment for inflation.
- D - DA
Data and Safety Monitoring Plan
For each NIH-supported clinical trial, NIH requires a data and safety monitoring plan that will provide oversight and monitoring to ensure the safety of participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks and the size and complexity of the clinical trial. A detailed data and safety monitoring plan must be submitted to the applicant's IRB and subsequently to the awarding IC for approval prior to the accrual of human subjects.
Data Universal Numbering System (DUNS)
A nine-digit number established and assigned by Dun and Bradstreet to uniquely identify a business entity.
Debarment and Suspension
The actions taken by a debarring official in accordance with OMB guidance at 2 CFR part 180, "Non-procurement Debarment and Suspension," as implemented by HHS in 2 CFR part 376, to exclude a person or organization from participating in grants and other non-procurement awards government-wide. If debarred or suspended, the person or organization may not receive financial assistance (under a grant, cooperative agreement, or subaward, or contract under a grant) for a specified period of time. Debarments and suspensions carried out pursuant to 2 CFR part 376 are distinct from post-award suspension action by an awarding agency. (See also Section 4.1.6 Debarment and Suspension
in the NIHGPS.)
Refers to the delay in the review of an application by a scientific review group, usually to the next review cycle, due to insufficient information.
Department of Health and Human Services (HHS)
Federal Executive Department of which the U.S. Public Health Service (PHS) is a component and the NIH is an agency of the PHS. Go to HHS.
Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy.
An application with a portion (or subproject) funded as a separate grant.
A charge to a grant that the Federal awarding agency determines to be unallowable in accordance with the applicable Federal cost principles or other terms and conditions contained in the award.
A public (including a State or other Governmental Agency) or private non-profit or for-profit organization located in the United States or its territories which is subject to U.S. laws and assumes legal and financial accountability for awarded funds and for the performance of the grant-supported activities.
Applications simultaneously assigned to two Institutes, Centers, or Divisions. The primary Institute has complete responsibility for administering and funding the application; the secondary assumes this responsibility only if the primary is unable or unwilling to support it.
Dual Review System
Peer review process used by NIH. The first level of review provides a judgment of scientific merit. The second level of review (usually conducted by an ICD's advisory Council) assesses the quality of the first review, sets program priorities, and makes funding recommendations.
- E - E-Business Point of Contact (POC)
An E-Business POC for an organization is designated during organization registration with the System for Award Management (SAM) and is the person responsible for the administration and management of grant activities in his/her organization. E-Business POCs give representatives of their organization the privilege to submit grant applications through Grants.gov by designating Authorized Organization Representative (AOR) authority.
Early Stage Investigator (ESI)
An individual who is classified as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI). See definition of New Investigator
A requirement by Congress that a Federal Agency spend a specified amount of money for a stated purpose (e.g. to establish a centers program or conduct a clinical trial).
Electronic Research Administration (eRA)
NIH's electronic invention reporting system. Go to iEdison
Electronic Streamlined Non-Competing Award Process (eSNAP)
The NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical and behavioral investigators worldwide. Registration is required. Go to eRA
Employer Identification Number
Electronic submission of a Non-Competing continuation progress report, through the eRA Commons, for an award subject to the SNAP (Streamlined Non-Competing Award Process) provisions. Use of eSNAP is mandatory for SNAP awards (see NOT OD-10-093
Identification of a business to the U.S. Internal Revenue Service; also known as a Federal tax identification number (TIN). The TIN forms the basis for the Entity Identification Number
Provides race and ethnicity data for the cumulative number of human subjects enrolled in an NIH-funded clinical research study since the protocol began. This data is provided in competing continuation applications and annual progress reports.
Entity Identification Number (EIN)
A three-part coding scheme of 12 characters used in the Program Management System (PMS) to identify organizations and individuals. The first character identifies the recipient as an organization or an individual. The next nine characters are the Employer Identification Number. The last two characters are a suffix to provide distinction between organizational entities that are assigned a single EIN and those that have more than one.
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 $5,000 or the capitalization threshold established by the organization, whichever is less.
A secure meeting place on the Web where research organizations and grantees electronically receive and transmit information about the administration of biomedical and behavioral research grants. Registration is required.
At this site:
Applicants access the status of their applications.
Grantees access the status of their awards, submit reports and make requests electronically.
Go to eRA Commons
During the process of submitting a grant application electronically, applicants may receive a notification of errors from the eRA Commons. Errors are critical problems with the application such as significant inaccuracies, inconsistencies or omissions.
Expanded Authorities (EA)
Errors stop the application from processing and must be corrected by the submission deadline in order for the application to move forward in the submission process.
Operating authorities provided in Federal Administrative Regulations (e.g., A-110) to grantees that waive the requirement for prior approval for specified actions. NIH extended expanded authorities to all NIH awards except for the provision to automatically carry over unobligated balances thus these authorities have become the NIH Standard Terms of Award. Therefore, the term Expanded Authorities is no longer used at NIH (see Administrative Requirements-Changes in Project and Budget-NIH Standard Terms of Award
In context of awarded grant:
The date signifying the end of the current project period, after which the grantee is not authorized to obligate grant funds.
In context of funding opportunity announcement key dates:
The day after the last submission due date for the announcement. As of the Expiration Date, the announcement is no longer active and applications will not be accepted unless either the late policy or system issue policy apply.
Funds provided by the NIH to researchers and organizations outside the NIH.
Research supported by NIH through a grant, contract, or cooperative agreement.
- F - Facilities and Administrative Costs
Costs that are incurred by a grantee for common or joint objectives and cannot be identified specifically with a particular project or program. These costs are also known as "indirect costs."
The simultaneous submission and concurrent review of a combined Phase I/Phase II SBIR or STTR grant application. This option is intended to reduce/eliminate the funding gap between SBIR/STTR Phase I and Phase II projects.
Federal Acquisition Regulations (FAR)
Federal Advisory Committee Act (FACA)
Laws regulating government contracting. Go to FAR
A law enacted in 1972 to ensure that advice by the various advisory committees formed over the years is objective and accessible to the public.
Federal Demonstration Partnership (FDP)
A cooperative initiative among some Federal agencies, including NIH, selected organizations receiving Federal funding for research, and certain professional organizations. Its efforts include demonstration projects intended to simplify and standardize Federal requirements in order to increase research productivity and reduce administrative costs.
Federal Financial Report (FFR)
The Federal Financial Report (SF425) is a single form consolidating the collection of financial information previously collected on the Cash Transaction Report (SF 272 and the Financial Status Report (SF269). NIH grantees now required to submit all required expenditure reports using the FFR. Further all FFR expenditure reports must be submitted to NIH electronically through the eRA Commons.
Federal Funding Accountability and Transparency Act (Transparency Act)
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.
Federal Technology Transfer Act (FTTA)
An official, daily publication communicating proposed and final regulations and legal notices issued by federal agencies, including announcements of the availability of funds for financial assistance. Go to Federal Register
Authorizes Government Agencies to enter into CRADAs with private companies.
Federal-Wide Assurance (FWA)
The Federalwide Assurance is the only type of new assurance of compliance accepted and approved by OHRP for institutions engaged
in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46
, as well as the terms
An amount, in addition to actual, allowable costs, paid to an organization providing goods or services consistent with normal commercial practice. This payment also is referred to as profit. Go to Section 18.104.22.168 Profit or Fee in the NIHGPS
An NIH training program award where the NIH specifies the individual receiving the award. Fellowships comprise the F activity codes.
Final Peer-reviewed Manuscript
The author's final manuscript of a peer-reviewed article accepted for journal publication, including all modifications from the peer review process.
Final Proposal Revision (FPR)
After completion of negotiations, offerors are asked to submit a final proposal revision which documents all cost and technical agreements reached during negotiations.
Final Published Article
The journal's authoritative copy of the article, including all modifications from the publishing peer review process, copyediting and stylistic edits, and formatting changes.
Transfer by NIH of money or property to an eligible entity to support or stimulate a public purpose authorized by statute.
Financial Conflict of Interest
Financial Management Plan
A policy to establish consistency in funding which specifies levels for items such as the payline, programmatic reductions, and caps for re-competing grants.
Financial Status Report (FSR)
Financial Status Report (FSR) Role
A financial report due 90 days after the end of each budget period for those awards not under SNAP, and at the end of the competitive segment for those awards under SNAP, showing the status of awarded funds for that period. The report is mandatory for continued funding of the grant. The form numbers for FSRs are SF 269 and SF 269A. Note the FSR has been replaced with the FFR
In the NIH Commons
, allows members of your staff to process Financial Status Reports (FSRs) for submission to the NIH electronically. An account with only the FSR Role assigned can perform FSR tasks. An account can include multiple roles, including that of FSR.
Fiscal Year (FY)
Any of 235 research areas reported by the central NIH Office of Budget and through the public NIH Report
website. Categories may refer to research, conditions, diseases or crosscutting areas and break down the NIH funding for reporting purposes. Also known as reporting category.
The annual period established for Government accounting purposes. A Fiscal Year begins on October 1 and ends September 30 of the following year. Example: FY2011-Started October 1, 2010 and ends September 30, 2011.
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. A for-profit organization is considered to be a small business if it is independently owned and operated, if it is not dominant in the field in which research is proposed, and if it employs no more than 500 persons. (Also see definition for small business concern
The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to, (1) the involvement of human subjects or animals, (2) extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the grantee having an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Foreign travel for consultation is not considered a foreign component. Go to Chapter 16 Grants to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components
in the NIHGPS.
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 PD/PI.
Freedom of Information Act (FOIA)
Requires dissemination, upon request, of Government documents while ensuring protection of proprietary and other privacy act information. Go to FOIA
The number of days per week and/or months per year representing full-time effort at the applicant/grantee organization, as specified in organizational policy. The organization's policy must be applied consistently regardless of the source of support.
Funding Opportunity Announcement (FOA)
A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND
and in the NIH Guide for Grants and Contracts
Percentage of applicants that receive funding in a fiscal year.
- G - GAO
Human subject term indicating a classification of research subjects into women and men.
Government Accountability Office (GAO)
Government Printing Office (GPO)
An oversight organization reporting to Congress. Go to GAO
Produces and distributes Federal Government information products. Go to GPO
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 Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
Grant Compliance Review
A DHHS policy providing for an appeal by the grantee institution of post award administrative decisions made by awarding offices. The two levels of appeal are an informal NIH procedure and a formal DHHS procedure. The grantee must first exhaust the informal procedures before appealing to the DHHS Appeals Board. (See Grant Appeals Procedures
in the NIHGPS.)
An evaluation by grants management staff to assess an institution's business and financial management systems to ensure that regulations and policies are being followed.
Grant Start Date
Official date a grant award begins; same as the first day of the first budget period.
Grant-Supported Project or Activity
Those activities specified or described in a grant application or in a subsequent submission 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 them out.
Grants Management Officer (GMO)
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 activity. The grantee is the entire legal entity even if a particular component is designated in the NoA. The grantee is legally responsible and accountable to NIH for the performance and financial aspects of the grant-supported project or activity. Also known as awardee or recipient. See section 2.3.6 Legal Implications of Applications in the NIHGPS
for additional information.
Grants Management Specialist (GMS)
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 permit 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. See also Chief Grants Management Officer
A NIH staff member who oversees the business and other non-programmatic aspects of one or more grants and/or cooperative agreements. 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 grantees; and administering grants after award.
) has been designated by the Office of Management and Budget as the single access point for all grant programs offered by 26 Federal grant-making agencies. It provides a single interface for agencies to announce their grant opportunities and for all applicants to find and apply for those opportunities.
- H - HBCU
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
Health-Related Biomedical or Behavioral Outcome
The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. It is administered and enforced by the Office for Civil Rights, HHS. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. Decisions about applicability and implementation of the Privacy Rule reside with the researcher and the grantee organization. (See HIPAA Privacy Rule
High Risk/High Impact (HR/HI)
The pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects' biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
A category of applications identified by a scientific review group as having a high degree of uncertainty in approach but also a high potential for impact. NIH tracks how many of these applications are identified and funded.
Historically Black College or University (HBCU)
Any historically black college or university established prior to 1964 whose principal mission was and is the education of black Americans, and is accredited by a nationally recognized accrediting Agency or Association determined by the Secretary [of Education] to be a reliable authority as to the quality of training offered or is, according to such an Agency or Association, making reasonable progress toward accreditation.
A non-profit or for-profit hospital or medical care provider component of a non-profit organization (for example, a foundation). The term includes all types of medical, psychiatric and dental facilities, such as clinics, infirmaries, and sanatoria.
Human Subjects Assurance
A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. Regulations governing the use of human subjects in research extend to use of human organs, tissues, and body fluids from identifiable individuals as human subjects and to graphic, written, or recorded information derived from such individuals. (See section 4.1.14 Human Subjects Protections
in the NIHGPS and the OER Research Involving Human Subjects
A document filed by an institution conducting research on human subjects with the Office for Human Research Protections--HHS
which formalizes its commitment to protect the human subjects prior to receiving any HHS grant funding.
- I - IACUC
Interagency Edison (iEdison) allows government grantees and contractors to report government-funded inventions, patents, and utilization data to the government agency that made the award, as required by the federal Bayh-Dole Act
, its implementing regulations, and any related funding agreement terms and conditions.
Individual Ruth L. Kirschstein NRSA
The impact/priority score is the rating which is assigned to an individual application by a SRG, and designates the reviewers' assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of established review criteria. The impact/priority score is one mechanism by which the SRG makes a recommendation to the funding component concerning the application's scientific and technical merit. Impact/priority scores may be numeric (10-90) or alphabetical (ND, for example).
For additional information see post on paylines, percentiles and success rates
Person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research or undergo a medical procedure.
In giving informed consent, people may not waive legal rights or release or appear to release an investigator or sponsor from liability for negligence. Go to 21 CFR 50.20
A request for applications (RFA), request for proposals (RFP), or program announcement (PA) stating the Institute or Center's interest in receiving research applications in a given area because of a programmatic need or scientific opportunity. RFAs and RFPs generally have monies set aside to fund the applications responding to them; program announcements generally do not.
The NIH organizational component responsible for a particular grant program or set of activities.
Public or Private entity, including Government Agencies.
Institutional Animal Care & Use Committee (IACUC)
Institutional Base Salary
The PHS Policy on Humane Care and Use of Laboratory Animals incorporates the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training, and requires the grantee to maintain an animal care and use program based on the Guide for the Care and Use of Laboratory Animals. An Institutional Animal Care and Use Committee (IACUC) appointed by the Chief Executive Officer or designee, is federally mandated to oversee the institution's animal program, facilities, and procedures (Public Law 99-158, Sec. 495). IACUC review and approval is required for all PHS supported activities involving live vertebrate animals prior to funding.
Institutional Business Official
The annual compensation paid by an organization for an employee's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual is permitted to earn outside of duties for the applicant/grantee organization. Base salary may not be increased as a result of replacing organizational salary funds with NIH grant funds. Go to Section 7.9.1 Allowability of Costs/Activities-Selected Items of Cost-Salaries and Wages
Person working in a research organization's business office who has signature or other authority. That person is the same as Grants.gov's Authorized Organizational Representative (AOR) and the eRA Commons' Signing Official (SO).
Institutional Development Awards (IDeA)
Institutional Development Awards (IDeA) enhance biomedical and behavioral research in specific geographic areas. The Division of Research Infrastructure of the National Center for Research Resources (NCRR) provides IDeA grants to foster research within states that traditionally have not received significant levels of competitive funding from the National Institutes of Health (NIH).
Institutional Review Board (IRB)
An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated. The Institutional Review Board has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.
Institutional Ruth L. Kirschstein NRSA
Integrated Review Group (IRG)
A cluster of scientifically related Study Sections. Applications reviewed by the Center for Scientific Review are often initially assigned at the IRG level and then subsequently assigned to a specific Study Section or Special Emphasis Panel. This two-stage process assignment process provides the opportunity to gain a broad perspective of the areas of science covered by the IRG and to appreciate changes in emphasis and the emergence of new areas while ensuring each application is reviewed by the most appropriate review group.
An organization that identifies itself as international or intergovernmental, and 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.
Internet Assisted Review (IAR)
Allows reviewer to submit critiques and preliminary scores for applications they are reviewing. Allows Reviewers, SRAs, and GTAs to view all critiques in preparation for a meeting. IAR creates a preliminary summary statement body containing submitted critiques for the SRA or GTA.
A manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
Research conducted by, or in support of, employees of the NIH.
Investigational New Drug (IND)
The requirement pursuant to 37 CFR part 401 that recipients of contracts, grants or cooperative agreements fully disclose any subject inventions made during the performance of work under a funding agreement in order to protect the Federal government's rights. See also Edison
A new drug or biological drug that is used in a clinical investigation.
Investigational New Drug Application
Under regulation 21 CFR 312, application filed by a drug sponsor with FDA on Form FDA 1571 to conduct clinical trials, including detailed descriptions of all phases, protocols, IRB members, and investigators. Once clinical evaluation is completed, a new drug application must be submitted to FDA to obtain approval to market the drug.
Research funded as a result of an investigator, on his or her own, submitting a research application. Also known as unsolicited research. Unsolicited applications are reviewed by chartered CSR review committees.
Institutional Profile File (IPF) number is a unique number used by NIH for tracking/reporting awards to grantee institutions.
- J - Just-In-Time (JIT)
NIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review when the application is under consideration for funding. This process is known as "Just-in-Time". Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. For more on the Just-in-Time policy see section 2.5.1 Just-In-Time Procedures in the NIHGPS. For more on the eRA Commons Module, see the eRA site for Applicants (Pre-Award).
- K - Key Personnel
- L - Letter of Intent
Some ICs request prospective applicants to submit letters of intent prior to the submission of a grant application. The letter usually includes the name, address and phone number of the PI, identifies other key personnel and participating institutions, and the RFA or PA identification. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows institute staff to estimate the potential review workload and plan for the application.
LikeThis is a new search tool to aid Principal Investigators in finding and learning about other research projects that have similar goals and objectives as their own. By entering specific scientific terms or accessing their own grant applications or grants and clicking on LikeThis, investigators will be provided a listing of similar funded projects and/or publications.
See the LikeThis Overview
- M - Matching or Cost Sharing
The value of third party in-kind contributions and the portion of the costs of a federally assisted project of program not borne by the Federal Government. Matching or cost sharing may be required by statute or program regulation. Costs used to satisfy matching or cost sharing requirements are subject to the same policies governing allowability as other costs under the approved budget.
Material Transfer Agreement (MTA)
A legal document defining the conditions under which research or other materials can be transferred and used among research laboratories.
Medical Scientist Training Program (MSTP)
Extramural research awards are divided into three main funding mechanisms: grants, cooperative agreements and contracts. A funding mechanism is the type of funded application or transaction used at the NIH. Within each funding mechanism NIH includes programs
. Programs can be further refined by specific activity codes
The Medical Scientist Training Program
(MSTP) supports the integrated medical (or equivalent professional clinical) degree and graduate research training required for the investigation of human diseases. MSTP assures highly selected trainees a choice of a wide range of pertinent graduate programs in the biological, chemical, and physical sciences which, when combined with training in medicine, lead to the M.D.-Ph.D. degree.
Minority Access to Research Careers (MARC)
National Library of Medicine's database for scientific publications. See PubMed
A program to provide special research training opportunities in the biomedical sciences for students and faculty at 4-year colleges and health professional schools in which substantial student enrollments are from minority groups.
Minority Biomedical Research Support (MBRS)
Model Organism Sharing
Modified Summary Statement
A program to strengthen the biomedical research and research training capability of ethnic minority institutions. The intent is to increase the involvement of minority faculty and students in biomedical research. See Minority Biomedical Research Support
Former term for a summary statement containing reviewer critiques, which is now standard practice. See Summary Statement
A type of grant application in which support is requested in specified increments without the need for detailed supporting information related to separate budget categories. When modular procedures apply, they affect not only application preparation but also review, award, and post-award administration. Go to Modular
A process whereby the programmatic and business management performance aspects of a grant are assessed by reviewing information gathered from various required reports, audits, site visits, and other sources.
Multi-project Grant Application
Multi-Year Funding (MYF)
A multi-project application is a single grant application submission with multiple, interrelated components with defined work, personnel,sites and budgets that share a common focus or objective.
Multi-year funded (MYF) awards are where the project period and budget period are the same and are longer than one year. A no-cost extension of an existing grant does not constitute Multi-Year Funding.
Multiple Program Director/Principal Investigator
Multiple Program Director/Principal Investigator (multiple PD/PI) awards are an opportunity for multidisciplinary efforts and collaboration through a team of scientists under a single grant award. All PD/PIs share equally the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant 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 PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. Go to Multiple Principal Investigators
- N - Name Change
National Institutes of Health (NIH)
An action whereby the name of an organization is changed without otherwise affecting the rights and obligations of that organization as a grantee. See section 22.214.171.124 Change in Grantee Status
of the NIH Grants Policy Statement.
National Library of Medicine (NLM)
A Federal agency whose mission is to improve the health of the people of the United States. NIH is a part of the Public Health Service, which is part of the U.S. Department of Health and Human Services. Go to NIH
National Research Service Award (NRSA)
The National Library of Medicine (NLM), on the campus of the National Institutes of Health in Bethesda, Maryland, has been a center of information innovation since its founding in 1836. The world's largest biomedical library, NLM maintains and makes available a vast print collection and produces electronic information resources on a wide range of topics that are searched billions of times each year by millions of people around the globe.
As part of the Public Access policy, in Spring, 2013, at the earliest, NIH will delay processing of non-competing continuation grant awards if publications arising from that award are not in compliance with the NIH public access policy. Compliant publications must be registered on NLM via MyNCBI.
See Guide Notice NOT-OD-12-160
NIH National Center for Research Resources (dissolved 12/2011)
New Application (award, grant)
Refers to an application not previously proposed, or one that has not received prior funding. Also known as a Type 1.
NIH Director's Pioneer Award
A PD/PI who has not previously competed successfully as a PD/PI for a substantial independent research award is considered a New Investigator. For example, a PD/PI who has previously received a competing NIH R01 research grant is no longer considered a New Investigator. However, a PD/PI who has received a Small Grant (R03) or an Exploratory/Developmental Research Grant Award (R21) retains his or her status as a New Investigator. A complete list of NIH grants that do not disqualify a PD/PI from being considered a New Investigator can be found at http://grants.nih.gov/grants/new_investigators/index.htm.
See also the definition of Early Stage Investigator
NIH Grants Policy Statement (NIHGPS)
The NIH Director's Pioneer Award supports individual scientists of exceptional creativity who propose pioneering approaches to major challenges in biomedical and behavioral research. The term "pioneering" is used to describe highly innovative - potentially transformative - approaches having the potential to produce an unusually high impact, and the term "award" is used to mean a grant for conducting research, rather than a reward for past achievements. Biomedical and behavioral research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences. Go to NIH Director's Pioneer Award
NIH Guide for Grants and Contracts
A consolidated resource of policy requirements that serve as the terms and conditions of NIH grant awards. It also provides general information about NIH-its organization, staff, and grants process. Current and historical versions of the NIHGPS can be found on the OER Grants Policy and Guidance
National Institutes of Health, Office of the Director
Non-Competing Continuation Application/Award
An extension of time to a project period and/or budget period to complete the work of the grant under that period, without additional Federal funds or competition. See sections 126.96.36.199
of the NIHGPS for additional information.
A financial assistance request (in the form of an application or progress report) or resulting award for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants.
Any corporation, trust, association, cooperative, or other organization that is operated primarily for scientific, educational, service, charitable, or similar purposes in the public interest; is not organized for profit; and uses net proceeds to maintain, improve, or expand the operations of the organization. Non-profit organizations include institutions of higher education, hospitals, and tribal organizations (that is, Indian entities other than federally recognized Indian tribal governments).
Not Recommended for Further Consideration (NRFC)
An application may be designated Not Recommended for Further Consideration (NRFC) by the Scientific Review Group if it lacks significant and substantial merit; presents serious ethical problems in the protection of human subjects from research risks; or presents serious ethical problems in the use of vertebrate animals, biohazards, and/or select agents. Applications designated as NRFC do not proceed to the second level of peer review (National Advisory Council/Board) because they cannot be funded.
Notice of Award (NoA)
A Notice (Guide Notice) is an official NIH announcement relating to a change in policy, procedure, form, or system. Notices are posted on the NIH website and users can be notified via a variety of NIH listservs. You can search for notices and funding opportunities at the NIH Guide
The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that:
notifies the recipient of the award of a grant;
contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and,
provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system.
- O - Objective Review
A process that involves the thorough and consistent examination of applications based on an unbiased evaluation of scientific or technical merit or other relevant aspects of the proposal. The review is performed by persons expert in the field of endeavor for which support is requested, and is intended to provide advice to the individuals responsible for making award decisions.
The amounts for which the recipient has made binding commitments for orders placed for property and services, contracts and subawards, and similar transactions during a funding period that will require payment during the same or a future period.
A contracting term denoting an applicant responding to a Request for Proposal (RFP).
Office for Human Research Protections (OHRP)
Office of Extramural Research (OER)
HHS office overseeing human subject protection for HHS-supported research. Go to OHRP
Office of Laboratory Animal Welfare (OLAW)
Office of Management and Budget (OMB)
The Office of Extramural Research, housed in the NIH Office of the Director, provides the corporate framework for the NIH research administration and works to ensure the scientific integrity, public accountability, and effective stewardship of the NIH research grant portfolio. Go to OER
Office of Research Information Systems (ORIS)
Executive Branch office assisting the U.S. president in preparing the Federal budget, evaluating agency programs and policies, and setting funding priorities. In setting policy, OMB issues Government-wide policy directives, called circulars that apply to grants.
Go to OMB's Grants Management Circulars
Provides IT systems, data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans' Administration) and works with the user community to provide efficient techniques for the conduct of extramural business. An office in the Office of Extramural Research, Office of the Director, NIH. The electronic Research Administration (eRA) and the Division of Information Services are part of ORIS.
Office of Research Integrity (ORI)
HHS office promoting integrity in biomedical and behavioral research supported by the Public Health Service by monitoring institutional investigations of scientific misconduct and facilitating the responsible conduct of research. Go to ORI
For an application to be considered on-time, all registrations must be completed and an error free application must be submitted to and accepted by Grants.gov with a timestamp on or before 5:00 p.m. local time of submitting organization on submission deadline date.
For both paper and electronic submissions, when these dates fall on a weekend or holiday, they are extended to the next business day.
Requests for Applications (RFAs) and Program Announcements with Special Referral Considerations (PARs) with special receipt dates always must be received (by Grants.gov for electronic applications and the Center for Scientific Review for paper applications) on the dates designated in the announcement to be on time.
See: NIH Policy on Late Submission of Grant Applications
First date an applicant can submit an electronic grant application to NIH through Grants.gov. NIH typically allows applications to be submitted up to 30 days in advance of a submission deadline.
A generic term used to refer to an educational institution or other entity, including an individual, which applies for or receives an NIH grant or cooperative agreement.
Other Research Grants
A two-letter code in the grant number identifying the first major-level subdivision of the funding organization.
3 R01 CA 12921(9) -04 S1A1
In the example above, "CA" refers to the National Cancer Institute. For certain activities, DHHS organizations having Bureau status may use a Division-level code. An interagency agreement awarded by NCI, for instance, may be coded 1Y01CM00999-00, where CM refers to NCI's Division of Cancer Treatment.
Also referred to as an IC (Institution or Center) Code or Admin PHS Org Code.
Other Significant Contributors (OSCs)
Research grants not classified as research projects or research centers. Includes the following:
R,P,M,S,K,U series (excluding UC6)
DP1, DP2, D42, G12.
Individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort (i.e., person months) to the project. These individuals are typically presented at "effort of zero person months" or "as needed." Individuals with measurable effort may not be listed as Other Significant Contributors (OSCs). Consultants should be included if they meet this definition.
Includes all financial resources, whether Federal, non-Federal, commercial or organizational, available in direct support of an individual's research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards. Other support does not include training awards, prizes, or gifts.
Overlap of Support
'Overall' is a special component type within a multi-project grant application, used by the applicant organization, with a single occurrence in every multi-project application. The Overall component typically contains information about the application as a whole and how the various other components fit together.
Other support duplicating research or budgetary items already funded by an NIH grant. Overlap also occurs when any project-supported personnel has time commitments exceeding 12 person months. See Scientific Overlap
- P - PA
Document issued by the U.S. Patent and Trademark Office
containing a description, specification, and claims that describe the subject matter in detail and giving its owner a right to exclude others from making, using, or selling it.
Only the inventor can obtain a patent; however, employers often require employees to hand over patent rights.
Requirement that the recipient of a NRSA postdoctoral fellowship engage in qualified research or teaching activities for a length of time equal to the period of NRSA support received. Only the first year of training incurs a payback obligation. In general, payback activity must involve at least 20 hours per week and be conducted over 12 consecutive months; special exceptions may be considered on a case-by-case basis. See section 11.4 Payback Requirements in the NIHGPS for additional information.
Payment Management System (PMS)
A percentile-based funding cutoff point determined by balancing the projected number of applications coming to an NIH Institute with the amount of funds available. Set after the budget is determined, paylines are not mandatory, are not made for all activity codes, and may be adjusted during the year.
For additional information see post on paylines, percentiles and success rates
The HHS centralized grants payment system operated by the Division of Payment Management, Program Support Center. Most HHS (and some other Federal government agencies') recipients receive grant payments through this system.
Peer Review Criteria
A form of objective review required by statute. It is an assessment of scientific or technical merit of applications by individuals with knowledge and expertise equivalent (peer) to that of the individuals whose applications for support they are reviewing, that is, reviewers who are the professional equals of the PD/PI for the proposed project and who often are engaged or were previously engaged in comparable activities. See Peer Review Process
for more information.
See Scored Review Criteria.
Permanent Resident Card
Represents the relative position or rank of each impact/priority score (along a 100.0 percentile band) among the scores assigned by a particular study section.
For additional information see post on paylines, percentiles and success rates
Shows a person's status as a permanent resident with a right to live and work permanently in the U.S. Commonly known as a "Green Card." Also called USCIS Form I-551. Go to U.S. Citizenship and Immigration Services
Phase IIB Competing Renewal
The metric for expressing the effort (amount of time) PD/PI(s), faculty and other senior/key personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year, academic year, and/or summer term; and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment. See also Frequently Asked Questions Regarding the Usage of Person Months
Phase III Clinical Trial
An application requiring competitive peer review and Institute/Center action to continue beyond the SBIR/STTR Phase II award.
PHS Policy on Humane Care and Use of Laboratory Animals
As defined by NIH, a broadly based prospective Phase III clinical investigation (usually involving several hundred or more human subjects) to evaluate an experimental intervention in comparison with a standard or control intervention or to compare two or more existing treatments. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials also are included. Go to Clinical Trial
Term and condition of all PHS awards involving live, vertebrate animals.
Planned Enrollment Report
The Planned Enrollment Report is used when you are planning to conduct a study that meets the NIH definition for clinical research. It provides a breakdown of the planned sample by sex/gender, race, and ethnicity.
An individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his or her chosen career path. (See the NIH-NSF Definition of a Postdoctoral Scholar
. (PDF - 85 KB))
A statement in summary form of the intent of the applicant to request funds. It is used to determine the applicant's eligibility and how well the project can compete with other applications and eliminate proposals for which there is little or no chance for funding.
Any cost incurred prior to the beginning date of the project period or the initial budget period of a competitive segment (under a multi-year award), in anticipation of the award and at the applicant's own risk, for otherwise allowable costs.
The annual budget request submitted to Congress by the U.S. President. The process begins with a budget request from the Institute or Center, which, as part of the entire NIH budget request, is modified by the Office of Management and Budget.
Presidential Early Career Award for Scientists and Engineers (PECASE)
Principal Investigator Work in Progress (PIW)
The Presidential Award is the highest honor bestowed by the U.S. Government on outstanding scientists and engineers beginning their independent careers. Go to PECASE
As used in the eRA Commons
, PIW is a possible status of an eSNAP (Electronic Streamlined Non-competing Award Process) report. The PIW status (or a different status) would appear in the eSubmission column of the PI List of Applicants/Grants hit list screen.
Written approval from the designated Grants Management Officer (GMO) required for specified post award changes in the approved project or budget. Such approval must be obtained before undertaking the proposed activity or spending NIH funds. See section 8.1.2 Prior-Approval Requirements
in the NIHGPS.
The Privacy Act of 1974, 5 U.S.C. 552a (as amended), and its implementing regulations (45 CFR part 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 acquisition of property or services for the direct benefit or use of the Government, generally via a contract.
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 the NIHGPS, "program" refers to those NIH programs carrying out their missions through the award of grants or cooperative agreements to other organizations.
Program Announcement (PA)
Program Announcement Reviewed in an Institute (PAR)
A PA is a formal statement about a new or ongoing extramural activity or program. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or program, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes. NIH may also make funds available through PARs (PAs with special receipt, referral, and/or review considerations) and PASs (PAs with set-aside funds).
PAs may be used for any support mechanism other than construction awards. Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated. PAs also are used to annually solicit applications for the SBIR and STTR programs. Those applications must be received by the dates specified in the PA.
Program Announcements (PA) are published in the NIH Guide for Grants and Contracts
. Go to Program Announcements
Program Announcement with special receipt, referral and/or review considerations.
Program Announcement with Set-Aside Funds (PAS)
Program Announcement with set-aside funds.
The need to balance an Institute's support of research in all its programmatic areas with its high-quality applications eligible for funding.
Program Classification Code (PCC)
An internal code unique for each I/C indicating the I/C's scientific interest and used to identify internal programs, branch classifications, the science or disease area, and sometimes program officials.
Program Director/Principal Investigator (PD/PI)
The individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the applicant 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 PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI.
Program Official (PO)/Program Officer/Project Officer
Gross income earned by the grantee organization that is directly generated by the grant-supported project or activity or earned as a result of the award. See section 8.3.2 Program Income
in the NIH GPS for additional information.
The NIH official responsible for the programmatic, scientific, and/or technical aspects of a grant.
The dollar amount a grant award is reduced from the amount recommended by the study section (scientific review group). This is done so Institutes can maintain a sufficient number of grants in their portfolio and to combat inflation of grant costs.
Periodic, usually annual, report submitted by the grantee and used by NIH to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report. This report may also be called the non-competing continuation progress report.
Commonly referred to as the application number or grant number, depending upon its processing status. This unique identification number for the grant is composed of the type code, activity code, Institute code, serial number, support year, and/or suffix code. See also Application Identification Numbers.
The total time for which Federal support of a project has been programmatically approved as shown in the NoA; however it does not constitute a commitment by the Federal government to fund the entire period. The total project period comprises the initial competitive segment, any subsequent competitive segment(s) resulting from a renewal award(s), and extensions.
A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
Public Access Compliance Monitor (PACM)
Formal description and design for a specific research
project. A protocol involving human subject research must be reviewed and approved by an Institutional Review Board (IRB) if the research is not exempt, and by an IRB or other designated institutional process for exempt research.
Public Access Policy
A web-based tool that institutions can use to track compliance of publications that fall under the NIH Public Access Policy.
Public Health Service (PHS)
The NIH policy designed to ensure that the public has access to the published results of NIH-funded research. See http://publicaccess.nih.gov/
Umbrella organization in the U.S. Federal Government consisting of eight HHS
health Agencies, the Office of Public Health and Science, and the Commissioned Corps (a uniformed service of more than 6,000 health professionals). The NIH is the largest Agency within the PHS. Go to Office of the Assistant Secretary for Health, HHS
PubMed provides access to citations from biomedical literature. It includes over 17 million citations from MEDLINE and other life science journals for biomedical articles back to the 1950s, along with links to full text articles and other scientific resources. These citations are indexed with a PMID, a series of numbers
PubMed Central (PMC)
PubMed Central Reference Number (PMCID)
PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal papers. These papers are indexed with a PMCID, a series of numbers preceded by 'PMC'. PMC content is publicly accessible and integrated with other databases. See: http://www.pubmedcentral.nih.gov/
PubMed ID Number (PMID)
The reference number assigned to an article or manuscript archived in PubMed Central
. The PMCID is the number that must be cited on applications, proposals or reports as part of compliance with the Public Access Policy
. See also "Citation ID."
The unique number assigned to a PubMed citation for an article published in a journal. This number does NOT indicate compliance with the Public Access Policy
- R - Rating Criteria
Land, including land improvements, structures, and appurtenances, but not movable machinery and equipment.
Receipt, Referral, and Assignment of Applications
Procedure for contesting the peer review of a grant application. Synonymous with appeal
Routing of applications arriving at NIH. The Division of Receipt and Referral (DRR) of CSR is the central receipt point for competing applications. The role of the DRR is to assign each application to a review group that has the expertise to evaluate the scientific and technical merit of the application and to one or more ICs for funding consideration. Information on the assignment of grant applications is accessed through the Commons
Reference Letter or Letters of Reference
Organizational entity or individual receiving a grant or cooperative agreement. See Grantee
Release Date/Posted Date
A reference letter (or reference form for individual fellowship programs) are letters of recommendation. Letters must be submitted by the same deadline as the grant application and can be submitted before the application itself, as early as the opening date of the Funding Opportunity Announcement (FOA). See Reference Letter FAQs
A request for assistance to extend for one or more additional budget periods a project period that would otherwise expire. Renewal applications compete for funds with other renewal applications, revised (supplemental) and new applications. The previous NIH term was "competing continuation." Also known as Type 2.
Request for Application (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 a Scientific Review Group (SRG) specially convened by the awarding component that issued the RFA.
Request for Proposals (RFP)
Announces that NIH would like to award a contract to meet a specific need, such as the development of an animal model. RFPs have a single application receipt date and are published in the NIH Guide for Grants and Contracts.
A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements. Also termed 'research and development.'
Research and Development (R&D) Contract
A funding mechanism by which the NIH procures specific services. These are negotiated contracts which may be funded from intramural or extramural accounts. Excluded are inter/intra-Agency agreements (Y01 and Y02), resource and support contracts (N02), and station support contracts (N03).
Research Career Awards (RCA)
Research Facilities Improvement Program (RFIP)
The National Center for Research Resources supports the Research Facilities Improvement Program
(RFIP). RFIP grants are provided to public and nonprofit private biomedical institutions to expand, remodel, and renovate or alter existing research and animal facilities or construct new research and animal facilities. Improvements under this program must support basic and/or clinical biomedical and behavioral research, and they may also support research training.
Extramural awards made for Other Research Grants, Research Centers, Research Projects, and SBIR/STTRs. Includes the following:
R,P,M,S,K,U series (excluding UC6)
DP1, DP2, D42, G12.
Research Performance Progress Report (RPPR)
Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results.
Fabrication is making up data or results and recording or reporting them.
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record.
Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
Research misconduct does not include honest error or honest differences of opinion.
Progress reports are required annually to document grantee accomplishments and compliance with terms of award. They describe scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. See http://grants.nih.gov/grants/rppr/
The cohort of grants supported by a given NIH organization.
Research Project Grant (RPG)
An award made to an institution/organization to support discrete, specified, circumscribed projects to be performed by named investigators in areas representing their specific interest and competencies. NIH's most commonly used grant program is the Research Project Grant Program (R01). See Types of Grant Programs
Research Supplement Programs for Special Populations
Includes the following selected Research Grant and Cooperative Agreement activities:
- R01, R03, R15, R21, R22, R23, R29, R33, R34, R35, R36, R37, R55, R56, RC1, P01, P42, PN1, U01, U19, UC1.
- In 1980 & 1981 activity code, U01 was not a research project
- From 1989 until 1992 activity code, R55 was not a research project
- In 1986 NINR did not have any research projects
- From 1984 until 1989 NCRR did not have any research projects
- FIC did not have any research projects until 1994
- From 1991 until 1996 NCRR did not consider R21's research projects
- NLM never had any research projects
An award made to an institution/organization to support discrete, specified, circumscribed projects to be performed by named investigators in areas representing their specific interest and competencies NIH's most commonly used grant program is the Research Project Grant Program (R01). See Types of Grant Programs
Responsible party is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to refer to the entity or individual who is responsible for registering a clinical investigation and submitting clinical trial information to the Clinical Trial Registry Data Bank. Responsible party is defined by the law as the sponsor of the clinical trial or the PD/PI of such clinical trial if so designated by a sponsor, contractor, grantee, or awardee, so long as the PD/PI is responsible for conducting the trial and has sufficient data rights. For the complete statutory definition and more detailed information see http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm
Special term and condition in a Notice of Award or article in a contract that limits activities and expenditures. It may be lifted or adjusted if the requirements are met.
An application that has been previously submitted, but was not funded, and is being resubmitted for new consideration. Applicants must make significant changes to the application and can only resubmit once the summary statement is available. Additional policies on resubmissions can be found in the applicable Application Instruction Guide. The previous NIH term was "revision." A resubmission has a suffix in its application identification number, e.g., A1.
See Resubmission Policy
The terms Study Section and Review Committee are normally used for continuing Scientific Review Groups in the Center for Scientific Review or NIH Institute, respectively. These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.
Refers to the Center for Scientific Review's thrice yearly initial peer review cycle, from the receipt of applications to the date of the review. See Standard Receipt Dates
As defined in the Federalwide SF424 (R&R): An application that proposes a change in 1) the Federal Government's financial obligations or contingent liability from an existing obligation, or 2) any other change in the terms and conditions of the existing award. Note in general for NIH applicants, #2 would not require the submission of another application. NIH grantees use revision applications to request an increase in support in a current budget period for expansion of the project's approved scope or research protocol. Applicants must apply and undergo peer review. The previous NIH term was "competing supplemental." NOTE: The former NIH term "revision," is now "resubmission". A revision has a suffix in its application identification number; e.g., S1.
Roadmap Initiative (RM)
Ruth L. Kirschstein National Research Service Awards (NRSA)
- S - Salary Cap/Limitation
Science Experts Network (SciENcv)
A legislatively-mandated provision limiting the direct salary (also known as salary or institutional base salary, but excluding any fringe benefits and F&A costs) for individuals working on NIH grants, cooperative agreement awards, and extramural research and development contracts. For current and historical salary cap levels, go to Salary Cap Summary
This new electronic system will enable researchers to easily assemble the information (including expertise, employment, education and professional accomplishments) to populate an NIH biographical sketch (biosketch). (Beta Version available Sept. 2013 â€“ See NIH Guide Notice NOT-OD-13-114)
Overlap of support occurs when substantially similar research is proposed in more than one concurrent PHS grant application.
Scientific Review Group (SRG)
Scientific Review Officer (SRO)
An SRG is a peer review committee of primarily non-government experts (peer reviewers), qualified by training or experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the applications under review, to evaluate and give expert advice on the scientific and technical merit of the applications.
A Scientific Review Officer (SRO) is the NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the Scientific Review Group and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h).
Scored Review Criteria
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 five criteria, among other pertinent factors: Significance, Investigator(s), Innovation, Approach, and Environment. These scored review criteria may not be applicable for some types of applications. When these criteria are not applicable, the FOA will include the specific review criteria. Reviewers will consider each of the five criteria 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. See Peer Review Process/Scoring
for additional information.
The funding of a small number of programmatically important applications at the margin of the payline as recommended by Council.
The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. "Zero percent" effort or "as needed" is not an acceptable level of involvement for senior/key personnel. See also Senior/Key Personal
Frequently Asked Questions.
A Service Provider is a commercial company that assists applicants, for a fee, in submitting grant applications electronically through Grants.gov to NIH and other federal agencies. See Service Providers
Money taken out of the budget for a specific purpose, for example, to fund a congressionally mandated program.
Sharing Model Organisms
A threshold that is reached when expenditures in a single direct cost budget category deviate (increase or decrease) from the categorical commitment level established for the budget period by more than 25 percent of the total costs awarded. Significant re-budgeting is one indicator of change in scope.
Signing Official (SO)
Small Business Concern
A Signing Official (SO) has institutional authority to legally bind the institution in grants administration matters. The individual fulfilling this role may have any number of titles in the grantee organization. The label, "Signing Official," is used in conjunction with the NIH eRA Commons
. The SO can register the institution, and create and modify the institutional profile and user accounts. The SO also can view all grants within the institution, including status and award information. An SO can create additional SO accounts as well as accounts with any other role or combination of roles. For most institutions, the Signing Official (SO) is located in its Office of Sponsored Research or equivalent.
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.
Small Business Innovation Research (SBIR)
Small Business Technology Transfer (STTR)
A program designed to support small business concerns conducting innovative research/research & development with potential for commercialization. For the computation of success rates, SBIR awards are not included in the count of RPGs. Go to Small Business Funding Opportunities.
A program designed to support cooperative research/research & development with potential for commercialization, through a formal cooperative effort between a small business and a U.S. research institution. For the computation of success rates, STTR awards are not included in the count of RPGs. Go to Small Business Funding Opportunities.
A contracting term denoting the review process by which a contractor is selected.
Special Emphasis Panel (SEP)
Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.
A component of an application's Research Plan which describes concisely the goals of the proposed research and summarizes the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.. Includes the specific objectives of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology).
Standard Form 424 (Research & Related) [SF424 (R&R)]
The application data set used by NIH for the electronic submission of grant applications through Grants.gov to NIH. The data set is owned and maintained by Grants.gov and includes both federal-wide and agency-specific forms.
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 A gency or instrumentality of a State exclusive of local Governments. For purposes of NIH grants, federally recognized Indian Tribal Governments generally are considered State Governments. State institutions of higher education and State hospitals are not considered State Governments for HHS's general administrative requirements for grants and the NIHGPS.
Statement of Work (SOW)
In a contract proposal, the detailed description of the work to be performed under the contract.
Allows Principal Investigators to review the current status of all their grant applications and review detailed information associated with their grants. Institution Officials [i.e., Signing Official (SO) or Administrative Official (AO) associated with the institution] can see a summary view of grant applications, review the Notice of Grant Award, and access the Progress Report face page.
A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee.
Streamlined Non-Competing Award Process (SNAP)
Streamlined process that includes a number of provisions that modify annual progress reports, NoAs, and financial reports. Funds are automatically carried over and are available for expenditure during the entire project period. All NIH award notices identify whether the grant is subject to or excluded from SNAP.
Routinely applied to:
all 'K' awards and 'R; awards, except R35s. Awards excluded from SNAP are those that do not having the authority to automatically carry over un-obligated balances (centers, cooperative agreements, Kirschstein-NRSA institutional training grants, non-Fast Track Phase I SBIR and STTR awards, clinical trials (regardless of activity code),
Program Project Grants (P01s), R35s and awards to individuals. See section 188.8.131.52 Streamlined Non-Competing Award Process in the NIHGPS for additional information.
SNAP instructions for submitting the progress report appear in the PHS 2590 Non-Competing Continuation Progress Report
. When SNAP applies, the progress report must
be submitted electronically using the eSNAP module in eRA Commons.
In the peer review process, applications not considered by the Scientific Review Group to be in the more meritorious half are 'streamlined' and designated Not Discussed. Streamlined applications are not discussed at the review meeting and will not be assigned a numerical overall impact/priority score, but the applicants do receive the reviewers' critiques. Streamlined applications will receive criterion scores from the assigned reviewers in addition to the reviewers' critiques to help applicants assess whether or not they should submit a resubmission application.
The terms Study Section and Review Committee are normally used for continuing Scientific Review Groups in the Center for Scientific Review or NIH Institute, respectively. These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.
A legal instrument by which a recipient provides funds (or property in lieu of funds) to an eligible subrecipient (or a lower-tier transaction) to perform a substantive portion of the grant-supported program or project. The term includes such financial assistance when provided by any legal agreement (even if the agreement is called a contract) but does not include any form of assistance which is excluded from the definition of grant
, including the recipient's procurement of property or services needed to carry out the project or program. The term includes consortium agreements.
A subproject is a discrete and clearly identifiable segment of a multicomponent application which has an identified project leader (may be different from the principal investigator on the application) and a separate budget. A subproject may include a scientific investigation, the provision of a service or resource, or a combination of activities and receives a specific review assignment and assessment (score and/or descriptor). Most commonly, subprojects are part of the M,P,S, and U mechanisms. A consortium/subcontract is not the same as a subproject.
A party that receives a subaward from a recipient or another subrecipient under a Federal financial assistance award and is accountable to the recipient or subrecipient for the use of the Federal funds provided by the subaward.
Success Rate Base
Indicates the percentage of reviewed RPG applications receiving funding computed on a fiscal year basis. It is determined by dividing the number of competing applications funded by the sum of the total number of competing applications reviewed and the number of funded carryovers.
NOTE: Applications having one or more amendments in the same fiscal year are only counted once. Success rate computations exclude SBIR/STTRs.
For additional information see post on paylines, percentiles and success rates
The basis for computing the Research Project Grant (RPG) success rate. It includes the total number of competing applications reviewed (the number of applications subjected to a streamlined review process).
Also known as Rate Base.
Process whereby the rights to and obligations under an NIH grant(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s). A SII may result from legislative or other legal action, such as a merger or other corporate change.
A combination of the reviewers' written comments and the SRO's summary of the members' discussion during the study section meeting. It includes the recommendations of the study section, a recommended budget, and administrative notes of special considerations.
A request for additional funds either for the current operating year or for any future year recommended previously.
Also known as a Type 3 application or award, a supplement can be either non-competing (administrative
) or competing (subject to peer review); however, the latter is now called 'Revision
Provides centralized support activities for grants management, program and peer review activities. Before the advent of DEAS, these activities were carried out by extramural staff located at individual Institutes and Centers.
System for Award Management (SAM)
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 the award. This meaning of the term "suspension" differs from that used in conjunction with the debarment and suspension process. (See section 4.1.6 Debarment and Suspension
in the NIHGPS for information on debarment and suspension).
As of July 2012, the System for Award Management (SAM) replaced the Central Contractor Registry (CCR).
The System for Award Management (SAM) is a website that consolidates Federal procurement systems and the Catalog of Federal Domestic Assistance (CFDA). Currently CCR, FedReg, ORCA and EPLS have been migrated to SAM. You must be registered on SAM (within the Entity Management section), Grants.gov and eRA Commons to successfully submit an application to NIH.
Most system issues are technical problems with federal systems used for electronic submission of grant applications (e.g., ASSIST, Grants.gov, eRA Commons, SAM) that keep an applicant from successfully submitting their grant application on time. System issues must be reported to the eRA Helpdesk on or before the deadline and will be investigated on a case by case basis. Please note: Problems with computer systems at the applicant organization, failure to complete required registrations by the submission deadline or failure to follow documented instructions are not typically considered system issues.
- T - Targeted Research
Targeted/Planned Enrollment Data
Research funded as a result of an I nstitute set aside of dollars for a specific scientific area. Institutes solicit applications using research initiatives (RFAs for grants, RFPs for contracts). Targeted research applications are reviewed by chartered peer review committees within I nstitutes. The opposite is Investigator-Initiated Research
Provides race and ethnicity data for projected number of human subject participants to be enrolled in an NIH-funded clinical research study. The data is provided in competing applications and annual progress reports.
Sharing of knowledge and facilities among F ederal laboratories, industry, universities, G overnment, and others to make federally generated scientific and technological advances accessible to private industry and S tate and local G overnments. Go to NIH Office of Technology Transfer
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 statue, regulation, policy, or other document referenced in the grant award, or specified by the grant award document itself. The Notice of Award may include both standard and special conditions that are considered necessary to attain the grant's objectives, facilitate post award administration of the grant, conserve grant funds, or otherwise protect the Federal Government's interests.
When applications are submitted collaboratively the applications are associated and reviewed as a single project. If selected for funding, each application will receive a separate award to fund the collaborative project. The awards may be linked together through special terms and conditions. Note this term may also apply when a single consolidated application is submitted involving multiple components that ultimately receive separate, but linked awards.
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.
Awards designed to support the research training of scientists for careers in the biomedical and behavioral sciences, as well as help professional schools to establish, expand, or improve programs of continuing professional education. Training awards consist of institutional training grants (T) and individual fellowships (F). Go to NIH Research Training Opportunities
Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.
Transparency Act (Federal Funding Accountability and Transparency Act)
The Federal Funding Accountability and Transparency Act of 2006, as amended ("Transparency Act"), requires the Office of Management and Budget to establish a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards. See Federal Funding Accountability and Transparency Act
- U - Underrepresented Group
Group underrepresented in the biomedical, clinical, behavioral, and social sciences, such as people with disabilities, people from disadvantaged backgrounds, and underrepresented racial and ethnic groups such as blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians and other Pacific Islanders.
Used as an eligibility requirement for diversity supplements, fellowships (F31), and other NIH programs. Also see and minority group
In an effort to streamline the Federal government's guidance on administrative requirements, cost principles, and audit requirements for Federal awards, the Office of Management and Budget has issued final guidance (referred to as â€˜Uniform Guidanceâ€™) that supersedes A-21, A-87, A-110, A-122, A-89, A-102, A-133, and the guidance in circular A-50 on Single Audit Act follow-up. By consolidating these 8 circulars, the uniform guidance provides a streamlined format that improves both clarity and accessibility. It is located in Title 2 of the Code of Federal Regulations (CFR), Part 200. For more information, see https://cfo.gov/cofar/ for related links to 2 CFR 200, other guidance documents, and recently updated Frequently Asked Question. Note, for NIH grantees The Department of Health and Human Services is considered the implementing agency and will issue implementation guidance once approved by OMB.
The 50 States, territories, and possessions of the United States, the Commonwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the District of Columbia.
For reports prepared on a cash basis, the amount of obligations incurred by the recipient that has not been paid; or
For reports prepared on an accrued expenditure basis, the amount of obligations incurred by the recipient for which an outlay has not been recorded.
The portion of the funds authorized by the Federal agency for expenditure by the recipient that has not been obligated by the recipient.
USA Patriot Act
The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) (P.L. 107-56) amends 18 U.S.C. 10 and provides criminal penalties for possession of any biological agent, toxin, or delivery system of a type or in a quantity that is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The Act also establishes restrictions on access to specified materials. "Restricted persons," as defined by the Act, may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select agent.
- V - Validation
The system check made by NIH's electronic systems of grant applications against the NIH application guide and Funding Opportunity Announcement instructions. The process can generate errors or warnings.
- W - Warning
Warnings are notices that alert an applicant to pay particular attention to specific instructions in the funding opportunity announcement or the application guide. The applicant may choose whether or not they wish to correct the issue that prompted the warning; the application will move forward in the submission process even if the warning is not corrected. If the application does not comply with the instructions, the applicant may be notified of the problem later in the review process and the application may not be considered for review.
An application that has been removed for consideration of award by the Signing Official/Authorized Organization Representative.
Withholding of Support
A decision by NIH not to make a non-competing continuation award within the current competitive
- X - xTrain
xTrain provides program directors/principal investigators, university administrators, and trainees the ability to electronically prepare and submit PHS 2271 Statement of Appointment forms and PHS 416-7 Termination Notices associated with institutional research training grants, institutional career development awards, individual fellowships and research education awards.