The cost of an asset, including the cost to put it in place. When used with equipment (capital expenditure), the term means the net invoice price of property or supplies including cost of modifications, attachments, accessories, or auxiliary apparatus necessary to make the property usable for the purpose for which it was acquired. Other charges, such as the cost of installation, transportation, taxes, duty, or protective in-transit insurance, are included or excluded from the unit acquisition cost in accordance with the recipient's regular accounting practices. It does not include costs for rental of property or alteration and rental of real property.

A 3-character code used to identify a specific category of extramural research activity, applied to financial assistance 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 is on the NIH Web site at https://grants.nih.gov/grants/funding/ac_search_results.htm.

A use of program income earned during or after the project period that permits income that is generated under a grant to be added to funds committed to the project by the Federal awarding agency and recipient and used to further eligible project or program objectives. (See definitions for deductive alternative and cost sharing or matching alternative and Administrative Requirements—Management Systems and Procedures—Program Income.)

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.

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.

A payment made to a recipient before the recipient disburses the funds for program purposes.

The process of assigning costs to one or more cost objectives, in reasonable and realistic proportion to the benefit provided or other equitable relationship. For additional information, see Cost Considerations—The Cost Principles.

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 Cost Considerations—The Cost Principles.

Work that 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. See also definitions for Major A&R and Minor A&R.

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 clinical trials that may be subject to the registration and results reporting requirements in FDAAA.

Those receipts that offset or reduce direct or indirect costs. Typical examples of such transactions include purchase discounts, rebates, or allowances; recoveries or indemnities on losses, insurance refunds; and adjustments of overpayments or erroneous charges.

A request for financial support of a project or activity submitted to NIH on specified forms and in accordance with NIH instructions. (See Application Information and Processes for detailed information about the application process, including an explanation of the types of applications.)

A single-digit code identifying the type of application received and processed.

Application type codes include the following: 1=New; 2=Renewal; 3=Revision; 4=Extension; 5=Non-Competing Continuation; 6=Change of Organization Status (Successor-In-Interest); 7=Change of Grantee or Training Institution; 8=Change of Institute or Division (Type 5 transfer to another NIH IC); 9=Change of Institute or Division (Type 2 transfer to another NIH IC).

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 and 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 NoA 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.

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.

The process of resolving audit findings, including those related to management and systems deficiencies and monetary findings (that is, questioned costs).

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 individual is equivalent to the signing official in the eRA Commons, i.e., holds the SO Role.

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.

The NIH IC responsible for the award, administration, and monitoring of grant supported activities.

The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes.

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. (See Administrative Requirements—Changes in Project and Budget—Prior Approval Requirements—Capital Expenditures.)

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.

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 Administrative Requirements—Changes in Project and Budget—Prior Approval Requirements—Change of Scope for additional information.

Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the expiration of the approved project period (competitive segment).

A process, usually initiated by the grantee, whereby the federally approved PD/PI is replaced by another individual, with the approval of the GMO.

The Grants Management Officer within an awarding agency who is the principal Grants Officer in the agency. The Chief Grants Management Officer 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.

Research with human subjects that is:

1. 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:
   1. mechanisms of human disease
   2. therapeutic interventions
   3. clinical trials
   4. development of new technologies
2. Epidemiological and behavioral studies.
3. Outcomes research and health services research.

Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.

A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits this definition of a clinical trial. Human subjects research to develop or evaluate clinical laboratory tests (e.g., imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test itself imposes more than minimal risk for the subjects.

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.

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.

The codified regulations of the Federal government based on the final agency regulations published in the Federal Register.

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.

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 NIHGPS, nor is it a role implying multiple PD/PI.

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 (up to 5 years) or each extension of a project period resulting from a renewal award.

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.

A grant whose purpose is to support activities related to the conduct of a conference(s) or defined set of conference-related activities.

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 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 subaward relationship. (See Consortium Agreements chapter in IIB.)

Construction of new buildings 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. 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 Construction chapter in IIB.

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.)

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 Multiple PI chapter in IIB for additional information.

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.

A type of financial assistance 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.

Any amount charged in excess of the Federal share of costs for the project period (competitive segment).

The government-wide principles, issued by OMB (or, in the case of commercial organizations, the Federal Acquisition Regulation [48 CFR 21], or, in the case of hospitals, 45 CFR 74, Appendix E, "Principles For Determining Costs Applicable to Research and Development Under Grants and Contracts with Hospitals"), on allowability and unallowability of costs under federally sponsored agreements. See Cost Considerations—The Cost Principles for additional details.

See matching or cost sharing definition.

cost sharing or matching alternative

An alternative use of program income whereby income accrued during the period of grant support may be used to satisfy a cost sharing or matching requirement. (See also definitions for additive alternative and deductive alternative and Administrative Requirements—Management Systems and Procedures—Program Income.)

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.

The actions taken by a debarring official in accordance with OMB guidance at 2 CFR 180, "Non-procurement Debarment and Suspension," as implemented by HHS in 2 CFR 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 376 are distinct from post-award suspension action by an awarding agency. (See also Public Policy Requirements and Objectives—Debarment and Suspension.)

The process of collecting funds owed by recipients to the Federal government, which, under grants, generally are owed as a result of formal cost disallowances.

A document used to record a legal obligation of one party to pay a financial obligation to another in accordance with predetermined terms and conditions.

An alternative for the use of program income earned during the period of grant support under which allowable costs of the project or program to be paid by the Federal government are offset by the amount of the program income. (See also definitions for additive alternative and cost sharing or matching alternative and Administrative Requirements—Management Systems and Procedures—Program Income.)

A departure on a single-case or class basis from a regulatory or policy requirement. A single-case deviation represents a request for waiver or exception sought for one grant only that arises on a case-by-case basis. A class deviation involves more than one grant for which the same type of deviation action is being requested.

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.

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 that is located in the United States or its territories, is subject to U.S. laws, and assumes legal and financial accountability for awarded funds and for the performance of the grant-supported activities.

A nine-digit number established and assigned by Dun and Bradstreet to uniquely identify a business entity.

A three-part coding scheme of 12 characters used in 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 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.

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 public database maintained by the General Services Administration which is the official government-wide system of record for debarments, suspensions, and other exclusionary actions. (see also Public Policy Requirements and Objectives—Debarment and Suspension.)

The Electronic Research Administration (eRA) Commons is a virtual meeting place where NIH extramural grantee organizations, grantees, and the public can receive and transmit information about the administration of biomedical and behavioral research. The eRA Commons is divided into both unrestricted and restricted portions that provide for public and confidential information, respectively.

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).

Generally, the date signifying the end of the current project period, after which the grantee is not authorized to obligate grant funds.

Costs that are incurred by a grantee for common or joint objectives and that, therefore, cannot be identified specifically with a particular project or program. These costs also are known as indirect costs.

A cooperative initiative among some Federal agencies, including NIH, selected organizations receiving Federal funding for research, and certain professional associations. Its efforts include demonstration projects intended to simplify and standardize Federal requirements in order to increase research productivity and reduce administrative costs.

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.

When used in conjunction with the acquisition of real property, equipment, or supplies under an award (whether paid by Federal funds or satisfying some or all of a matching or cost sharing requirement), the dollar amount that is the product of the Federal share of project costs multiplied by the current fair market value of the property.

The amount, generally expressed both in dollars and as a percentage of the total approved budget for a project or program, whether provided as funds, property, or direct assistance provided by the Federal government. The Federal share and any non-Federal share are so noted in the NoA.

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 46, as well as the terms of assurance.

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. (See Grants to For-Profit Organizations—Small Business Innovation Research and Small Business Technology Transfer Programs—Allowable Costs and Fee—Profit or Fee.)

Transfer by NIH of money or property to an eligible entity to support or stimulate a public purpose authorized by statute.

A financial conflict of interest exists when the grantee's designated official(s) reasonably determines that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. See 42 CFR 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for which PHS funding is sought and Public Policy Requirements and Objectives—Financial Conflict of Interest.

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.)

For-profit organizations also are referred to as "commercial organizations."

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 that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Examples of other grant-related activities that may be significant are:

• collaborations with investigators at a foreign site anticipated to result in co-authorship;
• use of facilities or instrumentation at a foreign site; or
• receipt of financial support or resources from a foreign entity.

Foreign travel for consultation is not considered a foreign component. (See Grants to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components chapter in IIB.)

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.

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.

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.

A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH IC anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.

A grant number is a unique identifier for a grant composed of the application type code, activity code, Institute code, 6-digit serial number, support year and /or suffix code for the support year of the grant, or other information, such as a supplement (S1), resubmission (A1), or a fellowship’s institutional allowance. In Federalwide systems (e.g., USASpending.gov, FFATA/FSRS) the Federal Award Identifier Number (FAIN) is used to identify grants for Federalwide implications. Similar to the NIH Grant Number, the FAIN consists of the activity code, Institute code, and 6-digit serial number

Sample Grant Number: 1 R01 AI 123456-01 A1 S1

Sample FAIN: R01 AI 654321

Those activities specified or described in a grant application or in a subsequent submission that are approved by an NIH IC for funding, regardless of whether Federal funding constitutes all or only a portion of the financial support necessary to carry them out.

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 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.

Grants.gov (http://www.grants.gov/) 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.

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. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.

An 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.

A non-profit or for-profit hospital or a 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.

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 Public Policy Requirements and Objectives—Human Subjects Protections.)

The impact score is the rating which is assigned to an individual application by an 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 score is one mechanism by which the SRG makes a recommendation to the funding component concerning the application's scientific and technical merit. Impact scores may be numeric (10 – 90) or alphabetical (ND, for example).

A new drug or biological drug that is used in a clinical investigation.

See facilities and administrative costs definition.

Something new or improved, including research for (1) development of new technologies, (2) refinement of existing technologies, or (3) development of new applications for existing technologies. For the purposes of PHS programs, an example of innovation would be new medical or biological products for improved value, efficiency, or costs.

The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.

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.

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 may be 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. (See Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Salaries and Wages.)

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.

Property that does not have physical existence. The term includes copyrights, patents, and other intellectual property generated or developed under awards. It also includes copyrights for which assignments of rights are acquired under awards; patents and other intellectual property for which ownership is acquired under awards; loans, notes, and other debt instruments (even if considered tangible for some purposes); lease agreements; and stock and other instruments of property ownership.

The Intergovernmental Personnel Act Mobility Program provides for the temporary assignment of personnel between the Federal Government and state and local governments, colleges and universities, Indian tribal governments, federally funded research and development centers, and other eligible organizations. The goal of the Intergovernmental Personnel Act mobility program is to facilitate the movement of employees, for short periods of time, when this movement serves a sound public purpose.

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.

The requirement pursuant to 37 CFR 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.

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.

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. 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. See Completing the Pre-Award Process—Just-In-Time Procedures for additional information.

An amount defined in a contract and chargeable against funds due to the contractor for each day the contractor fails to complete the project beyond the contract completion date.

An A&R project under a grant whose primary purpose is other than construction or modernization, including a project involving modernization, improvement or remodeling, exceeding $500,000 in direct costs awarded for the project. Major A&R may include improvement, conversion, rearrangement, rehabilitation or remodeling. Major A&R does not apply to minor alterations, renovations or repairs funded under a research project grant or alterations or renovations funded under an NIH center grant. Major A&R is an unallowable activity or cost under foreign grants and foreign components in domestic grants.

The value of third-party in-kind contributions and the portion of the costs of a federally assisted project or program not borne by the Federal government. Matching or cost sharing may be required by 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.

Extramural awards are divided into three types of financial assistance: grants, cooperative agreements and contracts. A mechanism is the type of funded application or transaction used at the NIH. Within each mechanism NIH includes programs. Programs can be further refined by specific activity codes.

A legal action resulting in the unification of two or more legal entities. When such an action involves the transfer of NIH grants, the procedures for the recognizing a successor-in-interest will apply. When the action does not involve the transfer of NIH grants, the procedures for recognizing a name change will apply.

An A&R project under a grant whose primary purpose is other than construction or modernization, including a project involving improvement or remodeling, which does not exceed $500,000 in direct costs. Minor A&R is not an allowable activity or cost under grants to individuals or grants for limited purposes, such as grants in support of scientific meetings (conference grants). Routine maintenance and repair of the organization's physical plant or its equipment is not considered A&R; these types of costs are typically treated as F&A costs.

Alteration, renovation, remodeling, improvement, and/or repair of an existing building and the provision of equipment necessary to make the building suitable for use for the purposes of a particular program. The entire purpose of the modernization grant is to modernize biomedical research facilities. A modernization grant cannot support the conduct of any research.

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 of the application, award, and post-award administration.

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.

An action whereby the name of an organization is changed without otherwise affecting the rights and obligations of that organization as a grantee.

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 https://grants.nih.gov/grants/new_investigators/#definition.

See also the definition of Early Stage Investigator.

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 NIH Standard Terms of Award and Prior Approval Requirements.

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.

When cost sharing or matching is required as a condition of an award, the portion of allowable project/program costs not borne by the Federal government.

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).

The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that:

1. notifies the recipient of the award of a grant;
2. contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and,
3. provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system.

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.

Government-wide guidance issued to Heads of Federal agencies by the Director of OMB. OMB Circulars directly pertinent to grants include the following:

• cost principles (OMB Circular A-21, OMB Circular A-87, and OMB Circular A-122). See Cost Considerations—The Cost Principles for additional information;
• uniform administrative requirements (OMB Circular A-102 and OMB Circular A-110);
• audit requirements for non-profit organizations (OMB Circular A-133). See Monitoring—Audit for additional information.

Some (but not all) of these OMB Circulars have been reissued in Title 2 of the Code of Federal Regulations.

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.

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.

NIH-wide FOA enabling applicants to electronically submit an investigator-initiated grant application for a specific activity code, e.g., Research Project Grant (Parent R01).

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 Ruth L. Kirschstein National Research Service Awards—Payback for additional information.

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.

The process that involves the consistent application of standards and procedures that produce fair, equitable, and objective examinations of applications based on an evaluation of scientific or technical merit or other relevant aspects of the application. The review is performed by experts (Peer Reviewers) in the field of endeavor for which support is requested. Peer review is intended to provide guidance and recommendations to the NIH individuals responsible for making award decisions.

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.

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. (See also clinical trial definition.)

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.

Written approval from the designated 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 Administrative Requirements—Changes in Project and Budget—Prior Approval Requirements).

See definition for fee.

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 that carry out their missions through the award of grants or cooperative agreements to other organizations.

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.

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 Administrative Requirements—Management Systems and Procedures—Program Income).

The NIH official responsible for the programmatic, scientific, and/or technical aspects of a grant.

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.

Location(s) of where the work described in the research plan will be conducted.

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 segments resulting from a renewal award(s), and extensions.

Land, including land improvements, structures, and appurtenances, but not movable machinery and equipment.

The organizational entity or individual receiving a grant or cooperative agreement. See also definition for grantee.

An application requesting additional funding for a period subsequent to that provided by a current award. Renewal applications compete for funds with all other peer reviewed applications and must be developed as fully as though the applicant is applying for the first time. The previous NIH term was "competing continuation."

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."

The Research Administrator acts as a local agent of the AOR and/or PD/PIs providing day-to-day grant-related support. See also Roles and Responsibilities—Grantee Staff.

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

1. Fabrication is making up data or results and recording or reporting them.
2. 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.
3. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
4. Research misconduct does not include honest error or honest differences of opinion.

Costs of routine and ancillary services provided by hospitals to participants in research protocols.

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 under FDAAA for registering a clinical trial and submitting clinical trial information to ClinicalTrials.gov.

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. Applicants must apply and undergo peer review. 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.

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.

A peer review committee group 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. No more than one-fourth of the members of any SRG may be Federal employees, as noted in 42 CFR 52(h).

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 SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h).

The aims, objectives, and purposes of a grant; as well as the methodology, approach, analyses or other activities; and the tools, technologies, and timeframes needed to meet the grant's objectives. This includes the research or training plan included with the original grant application, along with any approved modifications.

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.

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 rebudgeting is one indicator of change in scope.

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 SBA at 13 CFR 121.

The government of any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, any U.S. territory or possession, or any agency or instrumentality of a State exclusive of local governments. For purposes of NIH grants, federally recognized Indian tribal governments 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.

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.

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 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.

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.

All personal property excluding equipment, intangible property, debt instruments, and inventions of a contractor conceived or first actually reduced to practice in the performance of work under a funding agreement ("subject inventions"), as defined in 37 CFR 401, "Rights to Inventions Made by Non-profit Organizations and Small Business Firms Under Government Grants, Contracts, and Cooperative Agreements."

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 Public Policy Requirements and Objectives—Debarment and Suspension and Administrative Requirements—Enforcement Actions).

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.

All legal requirements imposed on a grant by NIH, whether based on statute, regulation, policy, or other document referenced in the grant award, or specified by the grant award document itself. The NoA 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.

The total allowable costs (both direct costs and F&A 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.

1. For reports prepared on a cash basis, the amount of obligations incurred by the recipient that has not been paid; or
2. 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 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.

The portion of the funds authorized by the Federal agency for expenditure by the recipient that has not been obligated by the recipient.

A decision by NIH not to make a non-competing continuation award within the current competitive segment.