The cost of the asset including the cost to ready the asset for its intended use. Acquisition cost for equipment, for example, means the net invoice price of the equipment, including the cost of any modifications, attachments, accessories, or auxiliary apparatus necessary to make it usable for the purpose for which it is acquired. Acquisition costs for software includes those development costs capitalized in accordance with generally accepted accounting principles (GAAP). Ancillary charges, such as taxes, duty, protective in transit insurance, freight, and installation may be included in or excluded from the acquisition cost in accordance with the non-Federal entity's regular accounting practices.

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 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 75, Appendix IX, "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. applicable to the organization incurring the cost or in the NoA Notice of Award: 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. 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 Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.; (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.

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: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies.

2) Epidemiological and behavioral studies.

3) Outcomes research and health services research

Studies falling under 45 CFR Part 46.101(b)(4) (the "Common Rule" prior to July 19, 2018 and 45 CFR Part 46.104(d)

4) (the "Revised Common Rule" effective July 19, 2018, Exemption 4) are not considered clinical research by this definition.

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

• See 45 CFR Part 46, Subpart A, referred to as the "Revised Common Rule" definition of research at 45 CFR Part 46.102(l). Pre-2018, see 45 CFR Part 46, Subpart A, referred to as the "Common Rule" definition of research at 45 CFR Part 46.102(d)
• See Revised Common Rule definition of human subject at 45 CFR Part 46.102(e)(1). See Common Rule definition of human subject at 45 CFR Part 46.102(f)
• The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignm ent of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.
• An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and treatment, prevention, and diagnostic strategies.
• A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and well-being or quality of life.

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 the Federal awarding agency or pass-through entity determines that all applicable administrative actions and all required work of the Federal award have been completed and takes actions as described in 2 CFR Part 200.344.

Charges made by a non-Federal entity to a project or program for which a Federal award was received.

1. The charges may be reported on a cash or accrual basis, as long as the methodology is disclosed and is consistently applied.
2. For reports prepared on a cash basis, expenditures are the sum of:
1. Cash disbursements for direct charges for property and services;
2. The amount of indirect expense charged;
3. The value of third-party in-kind contributions applied; and
4. The amount of cash advance payments and payments made to subrecipients.
3. For reports prepared on an accrual basis, expenditures are the sum of:
1. Cash disbursements for direct charges for property and services;
2. The amount of indirect expense incurred;
3. The value of third-party in-kind contributions applied; and
4. The net increase or decrease in the amounts owed by the non-Federal entity for:
1. Goods and other property received;
2. Services performed by employees, contractors, subrecipients, and other payees; and
3. Programs for which no current services or performance are required such as annuities, insurance claims, or other benefit payments.

Depending on the context, in either paragraph (1) or (2) of this section:

(1)(i) The Federal financial assistance that a non-Federal entity receives directly from a Federal awarding agency or indirectly from a pass-through entity, as described in 2 CFR Part 200.101; or

(ii) The cost-reimbursement contract under the Federal Acquisition Regulations that a non-Federal entity receives directly from a Federal awarding agency or indirectly from a pass-through entity, as described in 2 CFR Part 200.101.

(2) The instrument setting forth the terms and conditions. The instrument is the grant agreement, cooperative agreement, other agreement for assistance covered in paragraph (2) of Federal financial assistance, or the cost-reimbursement contract awarded under the Federal Acquisition Regulations.

(3) Federal award does not include other contracts that a Federal agency uses to buy goods or services from a contractor or a contract to operate Federal government owned, contractor operated facilities (GOCOs).

(4) See also definitions of Federal financial assistance, grant agreement, and cooperative agreement.

1. Federal financial assistance means assistance that non-Federal entities receive or administer in the form of:
1. Grants;
2. Cooperative agreements;
3. Non-cash contributions or donations of property (including donated surplus property);
4. Direct appropriations;
5. Food commodities; and
6. Other financial assistance (except assistance listed in paragraph (b) of this section).
2. For 2 CFR Part 200.202 and 2 CFR Part 200 Subpart F, federal financial assistance also includes assistance that non-Federal entities receive or administer in the form of:
1. Loans;
2. Loan Guarantees;
3. Interest subsidies; and
4. Insurance.
3. Federal financial assistance does not include amounts received as reimbursement for services rendered to individuals as described in 2 CFR Part 200.502(h) and (i).

1. All Federal awards which are assigned a single number in the Assistance listings.
2. When no Assistance listing number is assigned, all Federal awards to non- Federal entities from the same agency made for the same purpose should be combined and considered one program.
3. Notwithstanding paragraphs (1) and (2) of this definition, a cluster of programs. The types of clusters of programs are:
1. Research and development (R&D);
2. Student financial aid (SFA); and
3. ‘‘Other clusters,'' as described in the definition of Cluster of Programs.

• 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 Organizations, International Organizations, and Domestic Grants with Foreign Components chapter in IIB).

An entity that is:

1. A public or private organization located in a country other than the United States and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance;
2. A private nongovernmental organization located in a country other than the United States that solicits and receives cash contributions from the general public;
3. A charitable organization located in a country other than the United States that is nonprofit and tax exempt under the laws of its country of domicile and operation, and is not a university, college, accredited degree granting institution of education, private foundation, hospital, organization engaged exclusively in research or scientific activities, church, synagogue, mosque or other similar entities organized primarily for religious purposes; or
4. An organization located in a country other than the United States not recognized as a Foreign Public Entity.

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

A legal instrument of financial assistance between a Federal awarding agency or pass-through entity and a non-Federal entity that, consistent with 31 U.S.C. 6302, 6304:

1. Is used to enter into a relationship the principal purpose of which is to transfer anything of value from the Federal awarding agency or passthrough entity to the non-Federal entity to carry out a public purpose authorized by a law of the United States (see 31 U.S.C. 6101(3)); and not to acquire property or services for the Federal awarding agency or pass-through entity's direct benefit or use;
2. Is distinguished from a cooperative agreement in that it does not provide for substantial involvement between the Federal awarding agency or passthrough entity and the non-Federal entity in carrying out the activity contemplated by the Federal award.
3. Does not include an agreement that provides only:
1. Direct United States Government cash assistance to an individual;
2. A subsidy;
3. A loan;
4. A loan guarantee; or
5. Insurance.

See also Cooperative Agreement.

Revised Common Rule (45 CFR Part 46, effective July 19, 2018): A living individual about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Pre-2018 Common Rule (45 CFR Part 46, effective July 19, 2018): A living individual about whom an investigator (whether professional or student) conducting research:

1. Data through intervention or interaction with the individual; or
2. 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).

(1) Any payment that should not have been made or that was made in an incorrect amount (including overpayments and underpayments) under statutory, contractual, administrative, or other legally applicable requirements; and

(2) Includes any payment to an ineligible party, any payment for an ineligible good or service, any duplicate payment, any payment for a good or service not received (except for such payments where authorized by law), any payment that does not account for credit for applicable discounts, and any payment where insufficient or lack of documentation prevents a reviewer from discerning whether a payment was proper.

A process implemented by a non-Federal entity designed to provide reasonable assurance regarding the achievement of the following objectives for Federal award:

1. Transactions are properly recorded and accounted for, in order to:
1. Permit the preparation of reliable financial statements and Federal reports;
2. Maintain accountability over assets; and
3. Demonstrate compliance with Federal statutes, regulations, and the terms and conditions of the Federal award;
2. Transactions are executed in compliance with:
1. Federal statutes, regulations, and the terms and conditions of the Federal award that could have a direct and material effect on a Federal program; and
2. Any other Federal statutes and regulations that are identified in the Compliance Supplement; and
3. Funds, property, and other assets are safeguarded against loss from unauthorized use or disposition.

Modernization. Alteration, renovation, remodeling, improvement, expansion or repair of, or completion of shell space in an existing building (whether for storage or for human occupancy), necessary to make the building suitable for use for the purposes of a particular program. Modernization is distinct from construction in that it leaves the existing structure in place. This can range from updating flooring to replacing everything except for the existing mainframe and foundations. When the primary purpose of the award is to modernize biomedical research facilities, the grant cannot support the conduct of any research.

Alteration and renovation (A&R) activities are considered as modernization activities and are typically supported under research grants where the primary purpose for the grant is other than construction or modernization. The determination of whether proposed A&R is major, or minor is made by the NIH Program Official. Major A&R is an unallowable activity or cost under foreign grants and foreign components in domestic grants.

Examples of activities of Major A&R are as follows:

• A structural change (e.g., to the foundation, roof, floor or exterior load-bearing walls of a facility, or extension of an existing facility) to increase the floor area and/or change the function and purpose of a facility

Examples of activities of Minor A&R are as follows:

• Changes to physical characteristics (interior dimensions, surfaces, and finishes); internal environments (temperature, humidity, ventilation, and acoustics); or utility services (plumbing, electricity, gas, vacuum, and other laboratory fittings);

• Installation of fixed equipment (including casework, fume hoods, large autoclaves, biological safety cabinets);

• Replacement, removal, or reconfiguration of interior non-load bearing walls, doors, frames, or windows in order to place equipment in a permanent location;

• Making unfinished shell space suitable for purposes other than human occupancy, such as storage of pharmaceuticals; or

• Alterations to meet requirements for accessibility by physically disabled individuals.

A PD/PI who has not previously competed successfully as a PD/PI for a substantial NIH 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 their 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/#definition.

See also the definition of Early Stage Investigator.

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.

A cost that is questioned by the auditor because of an audit finding:

1. Which resulted from a violation or possible violation of a statute, regulation, or the terms and conditions of a Federal award, including for funds used to match Federal funds;
2. Where the costs, at the time of the audit, are not supported by adequate documentation; or
3. Where the costs incurred appear unreasonable and do not reflect the actions a prudent person would take in the circumstances.

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 "Fabrication, falsification, or plagiarism in proposing, performing, or reviewing 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." does not include honest error or honest differences of opinion.

For financial reports prepared on a cash basis, obligations incurred by the non- Federal entity that have not been paid (liquidated). For reports prepared on an accrual expenditure basis, these are obligations incurred by the non-Federal entity for which an expenditure has not been recorded.