Glossary

Filter By:
A B C D E F G H I K L M N O P Q R S T U V W X

NCI

NIH National Cancer Institute

A

Acquisition Cost

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.

Activity Code

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. Comprehensive List of Activity Codes

Administrative Requirements

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).

Advisory Council/Board

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.

Allowable Cost

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 the NIH Grants Policy Statement: 7 Cost Considerations 7.2 The Cost Principles.

Ancillary Study

An ancillary study is an adjunctive or supplemental study to an ongoing study. An ancillary study may or may not be a clinical trial. Determine whether an ancillary study is a clinical trial by answering the four questions that define NIH clinical trials based on the information about the ancillary study alone, regardless of the clinical trial status of the parent trial. An ancillary clinical trial is a trial for which the answer to the four questions is "Yes".

An ancillary clinical trial to a larger clinical trial may be considered an independent clinical trial if it includes an additional intervention to patients or a sub-population of patients within the larger clinical trial. An example of an ancillary study that is not a clinical trial could be research which involves analyses of stored samples collected in an ongoing clinical trial but no additional intervention to the human subjects/patients.

Application Cycle

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 Submission System & Interface for Submission Tracking (ASSIST) is a web-based system used to prepare grant applications using the SF424 Research & Related form set and to submit electronically through Grants.gov to NIH and other participating agencies. See Preparing Your Application Using ASSIST.

Appropriation Act

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.

Approved Budget

The financial expenditure plan for the grant-supported project or activity, including revisions approved by NIH as well as permissible revisions made by the grantee. The approved budget consists of Federal (grant) funds and, if required by the terms and conditions of the award, non-Federal participation in the form of matching or cost sharing. The approved budget specified in the 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.

Audit Finding

Deficiencies which an auditor is required by 45 CFR § 75.516(a) to report in the schedule of findings and questioned costs.

Audit Resolution

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

B

Bilateral Agreement

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.

Bioengineering Consortium

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).

Budget Appropriation

C

CGMO

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

Cluster of Programs

A grouping of closely related programs that share common compliance requirements. The types of clusters of programs are research and development (R&D), student financial aid (SFA), and other clusters. "Other clusters" are as defined by OMB in the compliance supplement or as designated by a state for Federal awards the state provides to its sub-recipients that meet the definition of a cluster of programs. When designating an "other cluster," a state must identify the Federal awards included in the cluster and advise the sub-recipients of compliance requirements applicable to the cluster, consistent with 45 CFR § 75.352(a). A cluster of programs must be considered as one program for determining major programs, as described in 45 CFR § 75.518, and, with the exception of R&D as described in 45 CFR § 75.501(c), whether a program-specific audit may be elected.

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.

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.

Cognizant Agency

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.

Cognizant Agency for Audit

The Federal agency designated to carry out the responsibilities described in 45 CFR § 75.513(a). The cognizant agency for audit is not necessarily the same as the cognizant agency for indirect costs. A list of cognizant agencies for audit may be found at the FAC Web site.

Cognizant Agency for Indirect Costs

The Federal agency responsible for reviewing, negotiating, and approving cost allocation plans or indirect cost proposals developed under this part on behalf of all Federal agencies. The cognizant agency for indirect cost is not necessarily the same as the cognizant agency for audit. For assignments of cognizant agencies see the following: (1) For IHEs: 45 CFR Pt 75, Appendix III, C.11. (2) For nonprofit organizations: 45 CFR Pt 75, Appendix IV, C.2. (3) For state and local governments: 45 CFR Pt 75, Appendix V, F.1. (4) For Indian tribes: 45 CFR Pt 75, Appendix VII, D.1.

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.

Contact PD/PI

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 NIH Grants Policy Statement: 9 Multiple Program director/Principal Investigator Applications and Awards)

Cooperative Agreement

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. 6302-6305: (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 pass through 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 government or pass-through entity's direct benefit or use; (2) Is distinguished from a grant in that it provides for substantial involvement between the Federal awarding agency or pass-through entity and the non-Federal entity in carrying out the activity contemplated by the Federal award. (3) The term does not include: (i) development agreement as defined in 15 U.S.C. 3710a; or (ii) An agreement that provides only: (A) Direct United States Government cash assistance to an individual; (B) A subsidy; (C) A loan; (D) A loan guarantee; or (E) Insurance.

Cost Objective

A program, function, activity, award, organizational subdivision, contract, or work unit for which cost data are desired and for which provision is made to accumulate and measure the cost of processes, products, jobs, capital projects, etc. A cost objective may be a major function of the non-Federal entity, a particular service or project, a Federal award, or an indirect (Facilities & Administrative (F&A)) cost activity, as described in 2 CFR 200, Subpart E-Cost Principles.

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 NIH Grants Policy Statement: 7 Cost Considerations 7.2 The Cost Principles for additional details.

Council Round

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.

Credential Field

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.

D

Debarment and Suspension

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 NIH Grants Policy Statement: 4 Public Policy Requirements, Objectives and Other Appropriation Mandates 4.1.6 Debarment and Suspension).

Debt Instrument

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.

Departmental Grants Appeals Board

The independent office established in the Office of the Secretary with delegated authority from the Secretary to review and decide certain disputes between recipients of HHS funds and HHS awarding agencies under 45 CFR Part 16 and to perform other review, adjudication and mediation services as assigned.

Domestic Organization

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.

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

Early Established Investigator (EEI)

A Program Director / Principal Investigator (PD/PI) who is within 10 years of receiving their first substantial, independent competing NIH R01 equivalent research award as an Early Stage Investigator (ESI).

Early Stage Investigator (ESI)

A Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm.

ECB-Council Portal and Archive

web-based system that provides a variety of services in support of the second level of review of grant applications by a review group

Expenditure Report

Means: (1) For non-construction grants, the SF-425 Federal Financial Report (FFR) (or other OMB-approved equivalent report); (2) for construction grants, the SF-271 "Outlay Report and Request for Reimbursement" (or other OMB-approved equivalent report)

F

Federal Award

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 45 CFR 75.101; 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 45 CFR 75.101.


(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.

Federal Award Identification Number

A unique number assigned to a financial assistance award to assist recipients in correctly reporting subawards. The public can use the FAIN and the CFDA number together to find one accurate result when searching on line in such databases as USASpending.gov and FSRS. The FAIN can be found on the notice of award. NIH implements the FAIN by deriving it from the core elements of the grant number. For example, the FAIN for 1R0lGM654321-01 would be R01GM654321.

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 Assistance

(1) For grants and cooperative agreements, Federal financial assistance means assistance that non-Federal entities receive or administer in the form of:

(i) Grants;

(ii) Cooperative agreements;

(iii) Non-cash contributions or donations of property (including donated surplus property);

(iv) Direct appropriations;

(v) Food commodities; and

(vi) Other financial assistance (except assistance listed in paragraph (b) of this section).

(2) For Subpart F of 45 CFR 75, Federal financial assistance also includes assistance that non-Federal entities receive or administer in the form of:

(i) Loans;

(ii) Loan Guarantees;

(iii) Interest subsidies; and

(iv) Insurance.

(3) Federal financial assistance does not include amounts received as reimbursement for services rendered to individuals as described in 45 CFR 75.502(h) and (i).

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 Program

(1) All Federal awards which are assigned a single number in the CFDA.

(2) When no CFDA 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:

(i) Research and development (R&D);

(ii) Student financial aid (SFA); and

(iii) "Other clusters,'' as described in the definition of Cluster of Programs.

Federal Register

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.

Federal Technology Transfer Act (FTTA)

Authorizes Government Agencies to enter into CRADAs with private companies.

Financial Assistance

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

A financial conflict of interest exists when the recipient'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 NIH Grants Policy Statement: 4.1 Public Policy Requirements and Objectives 4.1.10 Financial Conflict of Interest.

Financial Management Plan

A Financial Management Plan, also known as Funding Policy, is a policy to establish consistency in funding which specifies levels for items such as the payline, programmatic reductions, and caps for re-competing grants.
Was this page helpful?
Form Approved OMB# 0925-0648 Exp. Date 05/31/2021