For a complete list of acronyms only, go to Acronym List.
"A0" is a convenient way to refer to a new, renewal or revision application that has not been amended following the review of an application with the same project number.
The A1 suffix is typically seen as part of an application identification number or grant number and “A1” is often used to refer to a new, renewal, or revision application that is amended and resubmitted after the review of a previous application with the same project number.
Academic Research Enhancement Award (AREA - R15)
Grant award stimulating research at health professional academic institutions with not more than $6 million per year of NIH support in total costs in each of four or more of the last seven years. Go to AREA.
Related to electronic submission of applications, the Accession number is the Agency tracking number provided for the application after Agency validations.
As used by the eRA Commons, a personal account an individual uses to log into the eRA Commons which is identified by a unique combination of username and password.
Account Administrator (AA)
An individual typically in the grantee organization's central research administration office designated by a SO to facilitate the administration of NIH eRA Commons accounts. The AA can create, modify and/or remove the necessary accounts for these types: AO, AA, FSR, PI or ASST. Although the AA can create additional accounts, the AA cannot modify institutional profile (IPF) information.
Obtaining supplies or services by the federal government with appropriated funds through purchase or lease. See Contract.
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 grant meeting the following criteria:
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
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 the NIH Grants Policy Statement: 8. Administrative Requirements 8.3 Management Systems and Procedures-Program Income
Expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health.
The NIH Institute or Center (IC) to which the Center for Scientific Review (CSR) routes NIH grant applications for a funding decision. An IC may request to change this assignment if the application is more suited to another IC. Also referred to as primary assignment.
Administrative Official (AO)
In the eRA Commons, reviews the grant application for accuracy before the signing official submits the final application to the NIH.
The general business management practices that are common to the administration of all grants, such as financial accountability, reporting, equipment management, and retention of records. Uniform administrative requirements for grants are found in OMB Circular A-102 and OMB Circular A-110 (now found at 2 CFR Part 215).
A request for (or the award of) additional funds during a current project period to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.
Automated Data Processing
A payment that a Federal awarding agency or pass through entity makes by any appropriate payment mechanism, including a predetermined payment schedule, before the non-Federal entity disburses the funds for program purposes.
This term has the same meaning as set forth in 13 CFR part 121 – Small Business Size Regulations, §121.103, “How does SBA determine affliliation?” Further information about SBA’s affiliation rules and a guide on affiliation is available at http://www.SBIR.gov and http://www.SBA.gov/size.
Agency Data Integration Application (Manage Agency Data)
Allows Operating Divisions (OpDivs) to manage data in the IMPAC II system, including the ability to add, modify and retrieve Common Accounting Numbers (CAN) and Award Authorization data.
Includes: (1) projects relating to the etiology, epidemiology, natural history, diagnosis, treatment, or prevention of AIDS; (2) various sequelae specifically associated with the syndrome; and (3) preparation and screening of anti-AIDS agents as well as vaccine development, including both preclinical and clinical studies. Not all applications examining various influences on T-lymphocytes or retroviruses will be appropriate for the expedited AIDS review process. Applications only indirectly related to AIDS will be evaluated by established Scientific Review Groups (SRGs) appropriate to the scientific discipline during regular NIH review cycles and should not be submitted in response to the expedited AIDS receipt dates. Applicants are urged to take note of the yearly NIH Plan for HIV-Related Research and indicate how their application addresses the NIH priorities set forth in that Plan. The Plan can be found on the NIH Office of AIDS Research homepage
Alien Registration - Card
The process of assigning a cost, or a group of costs, to one or more cost objective(s), in reasonable proportion to the benefit provided or other equitable relationship. The process may entail assigning a cost(s) directly to a final cost objective or through one or more intermediate cost objectives. For additional information, see the NIH Grants Policy Statement: 7. Cost Considerations 7.2 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 the NIH Grants Policy Statement: 7 Cost Considerations 7.2 The Cost Principles.
Alteration and Renovation (A&R)
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.
Amendment (amended or revised applications)
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.
Animal Welfare Assurance
Document an institution and all performance sites involving animals in research must have on file with the Office of Laboratory Animal Welfare before a PHS Agency may award a grant or contract.
Animals in Research
Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes. The generation of custom antibodies and animals obtained or euthanized for tissue harvest constitute activities involving vertebrate animals. To learn more about policies and guidance on the use of animals in PHS funded research, training, and testing, see the NIH Office of Laboratory Animal Welfare.
In a FOA, the announcement type field refers to whether the FOA is new or a reissue.
Annual Payback Activities Certification (APAC)
Annual Payback Activities Certifications (APACs) for PHS 6031-1 are notices used by Kirschstein-NRSA recipients to report on their payback activities annually, until their payback obligation is fulfilled.
An appeal is a written communication from a Program Director/Principal Investigator (PD/PI) and/or applicant institution that meets the following four criteria: 1) is received after issuance of the summary statement and up to 30 calendar days after the second level of peer review, 2) describes a flaw or perceived flaw in the review process for a particular application, 3) is based on one or more of four allowable issues (described below), and 4) displays concurrence from the Authorized Organization Representative (AOR).
Applicable Clinical Trial
Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of 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.
Organization or person who actively applies but has not yet been awarded a grant.
A request for financial support of a project or activity submitted to NIH on specified forms and in accordance with NIH instructions. (See NIH Grants Policy Statement: 2.3 Application Information and Processes for detailed information about the application process, including an explanation of the types of applications).
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 Identification Numbers
The application number identifies:
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.
Application Type Code
A single-digit code identifying the type of application received and processed. Application type codes include the following:
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)
Application Viewing Window
Once an error-free application is submitted through Grants.gov to eRA, the eRA system assembles an application image and posts it in the PD/PI's Commons account. The PD/PI, any delegated Assistants, and the Signing Official (SO) have 2 business days to view the assembled application in Commons - just as a reviewer would see it. The application viewing window is linked to the time of submission, not the due date. It begins the day after the assembled application image is posted in Commons and excludes weekends and Federal holidays.
Within the viewing window, the SO can Reject the application and stop it from moving further in the process. After the viewing window, the application automatically moves forward for further consideration and the submission process is complete.
The statute that provides the authority for Federal agencies to incur obligations to and make payments out of the U.S. treasury for specified purposes.
The financial expenditure plan for the grant-supported project or activity, including revisions approved by NIH as well as permissible revisions made by the grantee. The approved budget consists of Federal (grant) funds and, if required by the terms and conditions of the award, non-Federal participation in the form of matching or cost sharing. The approved budget specified in the Notice of Grant Award may be shown in detailed budget categories or as total costs without a categorical breakout. Expenditures charged to an approved budget that consists of both Federal and non-Federal shares are deemed to be borne by the grantee in the same proportion as the percentage of Federal/non-Federal participation in the overall budget.
The award of money, property, or services to a recipient to accomplish a public purpose as authorized by Federal statute. Assistance relationships (e.g., grants) are expressed in less detail than are acquisition relationships (contracts), and responsibilities for ensuring performance rest largely with the recipient or are shared with the Government.
Assistant Role (ASST)
In the NIH Commons the role designed to allow PIs to delegate certain responsibilities for data entry of grant information and upkeep of their personal profiles. The ASST does not have any other functions in the system.
See Assistant Role
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.
Deficiencies which an auditor is required by 45 CFR § 75.516(a) to report in the schedule of findings and questioned costs.
The process of resolving audit findings, including those related to management and systems deficiencies and monetary findings (that is, questioned costs).
Authorized Organization Representative (AOR)
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.
Average Programmatic Reduction
The dollar amount a grant award is reduced from the amount recommended by the study section (scientific review group). This is done so Institutes can maintain a sufficient number of grants in their portfolio and to combat inflation of grant costs.
The provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.
Awarded Direct Costs
See Direct Costs.
Awarded Indirect Costs
See Indirect Costs.
Awarded Total Costs
See Total Costs.
The NIH Institute/Center (IC) responsible for the award, administration, and monitoring of grant supported activities.
Broad Agency Announcement
Basic Experimental Studies with Humans
Studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.
Systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (CFR 272.3)
The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212), implemented by 37 CFR 401, affords grantees the right to elect title and retain ownership to inventions they develop with funding under an NIH grant award. Under the regulations, grantees are required to report all subject inventions to the awarding agency, as well as include an acknowledgement of federal support in any patents.
Best and Final Offer (BAFO)
A general science agreement between the U.S. and a foreign country. Grant applications from institutions in these countries that have been recommended for approval by the scientific review group are given special funding consideration by Council.
The focus of bioengineering issues at the NIH which consists of senior-level representatives from each of the NIH Institutes, Centers, and Divisions plus representatives of other Federal Agencies concerned with biomedical research and development. Go to Bioengineering Consortium (BECON).
Biomedical Research and Development Price Index (BRDPI)
Measures real annual changes in the prices of items and services required for research and development (R&D) activities.
Bridge awards provide continued but limited interim support (bridge funding) for meritorious investigators who just miss the funding cutoff and have minimal support from other sources. The continued funding will permit the PD/PI additional time to strengthen a resubmission application. A Bridge award recipient usually will receive an R56 award for a single year. Investigators may not apply for R56 grants. Applications for conversion to an R56 will be selected by IC staff from reviewed applications that fall at or near the payline margins.
The financial plan for the project or program that the Federal awarding agency or pass-through entity approves during the Federal award process or in subsequent amendments to the Federal award. It may include the Federal and non-Federal share or only the Federal share, as determined by the Federal awarding agency or pass through entity. 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 recipient in the same proportion as the percentage of Federal/non-Federal participation in the overall budget.
See Appropriation Act.
Identifies the sub-mechanism category of the award for reporting purposes.
The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes.
Common Accounting Number
Commercialization Accelerator Program
Tangible or intangible assets used in operations having a useful life of more than one year which are capitalized in accordance with GAAP. Capital assets include: (1) Land, buildings (facilities), equipment, and intellectual property (including software) whether acquired by purchase, construction, manufacture, lease-purchase, exchange, or through capital leases; and (2) Additions, improvements, modifications, replacements, rearrangements, reinstallations, renovations or alterations to capital assets that materially increase their value or useful life (not ordinary repairs and maintenance).
Expenditures to acquire capital assets or expenditures to make additions, improvements, modifications, replacements, rearrangements, reinstallations, renovations, or alterations to capital assets that materially increase their value or useful life. (See NIH Grants Policy Statement: 8 Administrative Requirements 8.1 Changes in Project and Budget 8.1.2 Prior Approval Requirements-Capital Expenditures).
Career Development Awards (CDA, K Series)
Awards for candidates who wish to further develop their careers in biomedical, behavioral and clinical research. Applicants are generally required to hold a research or health–professional doctoral degree or its equivalent; eligibility for some CDAs is limited to only applicants with health professional doctoral degrees. See Career Development Awards.
Unobligated Federal funds remaining at the end of any budget period that, with the approval of the GMO or under an automatic authority, may be carried forward to another budget period to cover allowable costs of that budget period (whether as an offset or additional authorization). Obligated, but unliquidated, funds are not considered carryover.
Catalog of Federal Domestic Assistance (CFDA)
A database which helps the Federal Government track all programs it has domestically funded. Federal programs are assigned a number in the Catalog of Federal Domestic Assistance (CFDA) which is referred to as the "CFDA number."
Catalogue of Federal Domestic Assistance (CFDA) Number
The number assigned to a Federal program in the CFDA.
Center for Scientific Review (CSR)
The NIH component responsible for the receipt and referral of grant applications to the PHS, as well as the initial review for scientific merit of most applications submitted to the NIH.
Center grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They support long-term, multi-disciplinary programs of research and development.
Central Contractor Registration (CCR) Database
As of July 2012, Central Contractor Registry (CCR) has been replaced with the System for Awards Management (SAM).See System for Award Management (SAM)
CFDA Program Title
The title of the program under which the Federal award was funded in the CFDA.
Change in Scope
An activity whereby the objectives or specific aims identified in the approved grant application are significantly changed by the recipient after award. GMO prior approval is required for a change in scope to be allowable under an award. See NIH Grants Policy Statement: 8 Administrative Requirements 8.1 Changes in Project and Budget 8.1.2 Prior Approval Requirements 126.96.36.199 Change of Scope for additional information.
Change of PD/PI
A process, usually initiated by the recipient, whereby the federally approved PD/PI is replaced by another individual, with the approval of the GMO.
Change of Recipient Organization
Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment).
Chartered Advisory Committee
Any committee formed for advisory purposes composed not wholly of Federal officials. Under the Federal Advisory Committee Act, standing committees must be chartered, i.e., approved by their parent Agency in collaboration with the U.S. General Services Administration to ensure a properly balanced representation (geographical, women, minorities) and meet other legal requirements
Chief Grants Management Officer (CGMO)
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.
For the purposes of the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects, a child is defined as an individual under the age of 18 years. The intent of the NIH policy is to provide the opportunity for individuals, including children and older adults, to participate in research studies when there is a sound scientific rationale for including them and participation is appropriate under existing Federal guidelines. Thus, children must be included in NIH-conducted or supported human subjects research unless there are scientific or ethical reasons not to include them.
For the purpose of providing consent for research participation, the definition of a child stated within the DHHS Regulations (45 CFR part 46, Subpart D, Sec. 402) should be applied. Please see the NIH Human Subjects website or 45 CFR 46, Subpart D for more information.
The reference number used when citing papers falling under the NIH Public Access Policy on applications, proposals, or progress reports. The citation ID will be a PMCID or an alternative when the PMCID has not been assigned yet. See Citation Methods.
Depending on the context, either: (1) A written demand or written assertion by one of the parties to a Federal award seeking as a matter of right: (i) The payment of money in a sum certain; (ii) The adjustment or interpretation of the terms and conditions of the Federal award; or (iii) Other relief arising under or relating to a Federal award. (2) A request for payment that is not in dispute when submitted.
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 46.101(b) (4) (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 Common Rule definition of research at 45 CFR 46.102(d)
See Common Rule definition of human subject at 45 CFR 46.102(f)
The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of 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.
Clinical Trial Research Experience
The involvement of a student, postdoctorate, or early career faculty member in a clinical trial led by their mentor or other investigator, with the goal of obtaining clinical trial experience relevant to their research interests and career goals. A clinical trial research experience is one in which the participant is supervised by a more experienced investigator and is intended to prepare the participant to potentially lead an independent clinical trial in the future. The applicant can be part of the clinical trial team and can use the data generated during the clinical trial research experience in his/her proposed research project. NIH expects the mentor to assume overall responsibility of the trial including registering and reporting in clinicaltrials.gov and obtaining IRB approval.
Close Date or Closing Date
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 45 CFR § 75.381.
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.
Funding arrangement through which two or more Institutes or Centers share in the funding of a grant.
An individual involved with the PD/PI in the scientific development or execution of a project. The Co-Investigator (collaborator) may be employed by, or be affiliated with, the applicant/recipient organization or another organization participating in the project under a consortium agreement. A Co-Investigator typically devotes a specified percentage of time to the project and is considered senior/key personnel. The designation of a Co-Investigator, if applicable, does not affect the PD/PI's roles and responsibilities as specified in the NIH Grants Policy Statement, nor is it a role implying multiple PD/PI.
Code of Federal Regulations (CFR)
The codified regulations of the Federal government based on the final agency regulations published in the Federal Register.
With respect to private information or human biological specimens, coded means that:
Research that involves only coded private information/data or coded human biological specimens may not constitute human subjects research under the HHS human subjects regulations (45 CFR 46) if:
Individuals who provide coded information or specimens for proposed research and who also collaborate on the research involving such information or specimens are considered to be involved in the conduct of human subject research.
See Council on Financial Assistance Reform
The Federal agency which, on behalf of all Federal agencies, is responsible for: reviewing, negotiating, and approving cost allocation plans, indirect cost rate and similar rates; monitoring non-Federal audit reports; conducting Federal audits as necessary; and resolving cross-cutting audit findings. The cognizant agency under the applicable cost principles and under OMB Circular A-133 may be different for a given recipient.
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.
An organization, institution, corporation, or other legal entity, including, but not limited to, partnerships, sole proprietorships, and limited liability companies, that is organized or operated for the profit or benefit of its shareholders or other owners. The term includes small and large businesses and is used interchangeably with "for-profit organization."
The process of developing products, processes, technologies, or services and the production and delivery (whether by the originating party or others) of the products, processes, technologies, or services for sale to or use by the Federal government or commercial markets.
Funds used for non-competing (type 5 or ongoing awards), typically 70-80 percent of the dollars spent for research project grants.
Committee Management Officer (CMO)
NIH CMO: The NIH Committee Management Officer is responsible for managing the implementation of the Federal Advisory Committee Act. The NIH CMO is responsible for developing and managing all committee management policy and procedure development for dissemination to all NIH IC staff as well as to Federal advisory committee members. The CMO reviews and finalizes all advisory committee charters and nomination slates for approval by the Secretary, DHHS or the Director, NIH and insures an accurate presentation of NIH committee activity on a public website managed by the General Services Administration.
I/C CMO: Each IC has a CMO or uses the resources of a service center to support the committee management function within the Institute or Center. The IC CMO is responsible for developing charters for committees, preparing nomination and appointment documents for membership to committees, providing technical assistance to committee members, providing initial review of conflict of interest disclosures and other responsibilities.
The NIH Common Fund supports cross-cutting, trans-NIH programs, including those referred to as NIH Roadmap programs. See The NIH Common Fund.
See eRA Commons.
A set of FOAs that share a unified theme or initiative. These FOAs may use different activity codes. They are typically (but not always) published concurrently.
New or renewal applications that must undergo initial peer review.
See Renewal Application.
Competing Research Project Grant
An application for a Research Project Grant requiring peer review, as opposed to a non-competing continuation.
A contracting term denoting a group of proposals considered acceptable by the initial peer review group which are potential candidates for an award.
A request for (or the award of) additional funds during a current project period to support new or additional activities which are not identified in the current award that reflect an expansion of the scope of the grant-approved activities. Competitive revisions require peer review.
The initial project period recommended for support (in general, up to 5 years) or each extension of a project period resulting from a renewal award.
Appendix XI to 45 CFR 75 (previously known as the Circular A-133 Compliance Supplement).
For the purposes of applications and progress reports, a component is a distinct, reviewable part of a multi-project application or progress report for which there is a business need to gather detailed information identified in the funding opportunity announcement (FOA). Components typically include general information (component organization, project period, project title, etc.), performance sites, personnel, and budget. The FOA defines the construction and naming convention for the application; the funded application defines the construction and naming convention for the progress report. Components may also be referred to as "cores" or "projects." Note, for RPPR Question G.9, the term "foreign component" is distinct from "component" as defined here. However, a "foreign component" may also be a "component" in the RPPR. (See definition of foreign component for more information).
For example, a specific multi-project application includes one Administrative Core, two Core and three Project components. In this example, the application includes 6 components using three different component types (Administrative Core, Core, Project).
'Overall' is a special component type, used by the applicant organization, with a single occurrence in every multi-project grant application. The Overall component typically contains information about the application as a whole and how the various other components fit together.
Machines used to acquire, store, analyze, process, and publish data and other information electronically, including accessories (or "peripherals') for printing, transmitting and receiving, or storing electronic information. See also "supplies" and "information technology systems."
The earliest planning stage of an initiative [request for applications (RFA), request for proposals (RFP), or program announcement (PA)]. Concepts are brought before the Advisory Council for concept clearance. Not all concepts cleared by Council are published as initiatives depending on the availability of funds.
Conference (domestic or international)
A symposium, seminar, workshop, or any other organized and formal meeting, whether conducted face-to-face or via the Internet, where individuals assemble (or meet virtually) to exchange information and view 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
Conflict of Interest is a cross-cutting issue that affects many policy areas such as peer review, financial conflict of interest, and responsible conduct of research. There are different uses of this term throughout this document. It generally means that a competing personal interest could affect, or could appear to affect, an individual's judgment or could cause the individual's impartiality to be questioned. Conflicts of Interest (actual or potential) may arise in the objective review process or in other activities or phases of the financial assistance process. See also Financial Conflict of Interest for a specific definition covering that policy area.
A territorial division of a state from which a member of the United States House of Representatives is elected.
A formalized agreement whereby a research project is carried out by the recipient and one or more other organizations that are separate legal entities. Under the agreement, the recipient 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 the NIH Grants Policy Statement: 15 Consortium Agreements).
Dollar amounts adjusted for inflation, based on buying power in a selected base year. The BRDPI is used to determine constant dollars from current dollars.
Construction of new buildings or 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 the NIH Grants Policy Statement: 10 Construction, Modernization, or Major Alteration and Renovation of Research Facilities).
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, recipients 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 NIH Grants Policy Statement: 7 Cost Considerations 7.9 Allowability of Costs/Activities 7.9.1 Selected Items of Cost Consultant Services)
The fee paid by an institution to a salaried member of its faculty is allowable only in unusual cases and only if both of the following conditions exist: (1) the consultation crosses departmental lines or involves a separate operation; and (2) the work performed by the consultant is in addition to his or her regular workload.
In all other cases, consulting fees paid to employees of recipient or cost-type contractor organizations in addition to salary may be charged to PHS grant-supported projects only in unusual situations and when all of the following conditions exist: (1) the policies of the recipient or contractor permit such consulting fee payments to its own employees regardless of whether Federal grant funds are received; (2) the consulting services are clearly outside the scope of the individual’s salaried employment; and (3) it would be inappropriate or not feasible to compensate the individual for these services through payment of additional salary.
For additional clarification on the allowance and appropriateness of consulting fees, refer to the NIH Grants Policy Statement.
Consumer Price Index (CPI)
Measurement of changes in prices of a broad range of consumer items.
When multiple PD/PIs are designated, NIH requires that the applicant organization identify one of the PD/PIs as the Contact PD/PI to serve as a primary point of contact. Serving as Contact PD/PI confers no special authorities or responsibilities within the project team. The Contact PD/PI must meet all eligibility requirements for PD/PI status. However, as with the single PD/PI model, if the Contact PD/PI is not an employee, the applicant organization must have a formal written agreement with the Contact PD/PI that specifies an official relationship between the parties. (See NIH Grants Policy Statement: 9 Multiple Program director/Principal Investigator Applications and Awards)
As a way of recognizing their service to NIH, reviewers with substantial review service are permitted to submit their research grant applications (R01, R21, or R34) on a continuous basis and to have those applications undergo initial peer review in a timely manner. Read more about Continuous Submission.
A legal instrument by which a non-Federal entity purchases property or services needed to carry out the project or program under a Federal award. The term as used in 45 CFR 75 does not include a legal instrument, even if the non-Federal entity considers it a contract, when the substance of the transaction meets the definition of a Federal award or subaward. (See NIH Grants Policy Statement: 1 Glossary 1.2 Definition of Terms Subaward)
Contract Transaction Types
Government employee authorized to execute contractual agreements on behalf of the Government.
An entity that receives a contract. See contract.
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.
Cooperative Research and Development Agreement (CRADA)
Any agreement between one or more NIH laboratories and one or more non-Federal parties under which the PHS, through its laboratories, provides personnel, services, facilities, equipment, or other resources with or without reimbursement (but not funds to non-Federal parties) and the non-Federal parties provide funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory.
Cost Allocation Plan
Central service cost allocation plan or public assistance cost allocation plan.
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.
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 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.
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 NIH Grants Policy Statement: 8 Administrative Requirements 8.3 Management Systems and Procedures 8.3.2 Program Income.)
A contract or subcontract under a grant in which the contractor or subcontractor is paid on the basis of the allowable costs it incurs, with or without a fee.
Council on Financial Assistance Reform (COFAR)
The Council on Financial Assistance Reform (COFAR) is an interagency group of representatives from the eight largest grant-making agencies established to create a more streamlined and accountable structure to coordinate financial assistance. The COFAR works with Congress, Federal agencies, state, local and tribal governments, institutions of higher education, nonprofit organization, Federal Councils and other groups to improve Federal financial management. Established in October 2011, the COFAR is leading several efforts to improve delivery, management, coordination, and accountability of Federal grants and cooperative agreements, which includes the development of the uniform guidance. For more information, visit https://cfo.gov/cofar/.
At the NIH, there are at least three, and sometimes four, council rounds each fiscal year: October, January, May, and sometimes August. Application receipt dates, initial review dates, and council review dates all fall within one of these council rounds. Incoming grant applications all are assigned to a council round.
National Advisory Council or Board, mandated by statute, providing the second level of review for grant applications for each Institute/Center awarding grants. The Councils/Boards are comprised of both scientific and lay representatives. Council/Board recommendations are based on scientific merit (as judged by the initial review groups) and the relevance of the proposed study to an institute's programs and priorities. With some exceptions, grants cannot be awarded without recommendations for approval by a Council/Board.
Unless noted, the total number of grants shown, excluding administrative supplements.
Covered Small Business Concern
For purposes of the SBIR/STTR programs, a small business concern that:
See Consumer Price Index.
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.
An overall evaluation of a grant application prepared by a reviewer before an initial peer review meeting and presented to a Scientific Review Group at the meeting.
Cumulative Inclusion Enrollment Report
The Cumulative Inclusion Enrollment Report is used to report the sex/gender, race, and ethnicity of the actual participants that have been enrolled in the study or if an applicant is proposing a new study using an existing dataset/resource where the participants have already been enrolled.
For more details about completing these forms, please see the Supplemental Instruction Guide
Actual dollars awarded, without adjustment for inflation.
Data and Safety Monitoring Board (DSMB)
A formal, independent board of experts including investigators and biostatisticians that advise study investigators regarding the safety progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I and Phase II or other clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.
Data and Safety Monitoring Plan
Prior to award, this plan must be approved by the applicant’s IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.
Data Universal Numbering System (DUNS)
A nine-digit number established and assigned by Dun and Bradstreet to uniquely identify a business entity.
Debarment and Suspension
The actions taken by a debarring official in accordance with OMB guidance at 2 CFR 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).
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 NIH Grants Policy Statement: 8 Administrative Requirements 8.3 Management Systems and Procedures 8.3.2 Program Income.)
Refers to the delay in the review of an application by a scientific review group, usually to the next review cycle, due to insufficient information.
Delayed Onset Study
Research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.
Research plans can be described at time of application, but research will not immediately begin (will occur later in the funding period)
Department of Health and Human Services (HHS)
Federal Executive Department of which the U.S. Public Health Service (PHS) is a component and the NIH is an agency of the PHS. Go to HHS.Previously DHHS.
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.
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. (See NIH Grants Policy Statement 7.3 Direct Costs and Facilities and Administrative Costs)
An application with a portion (or subproject) funded as a separate grant.
Those charges to a Federal award that the Federal awarding agency or pass-through entity determines to be unallowable, in accordance with the applicable Federal statutes, regulations, or the terms and conditions of the Federal award.
A public (including a State or other Governmental Agency) or private non-profit or for-profit organization located in the United States or its territories which is subject to U.S. laws and assumes legal and financial accountability for awarded funds and for the performance of the grant-supported activities.
Applications simultaneously assigned to two Institutes, Centers, or Divisions. The primary Institute has complete responsibility for administering and funding the application; the secondary assumes this responsibility only if the primary is unable or unwilling to support it.
Dual Review System
Peer review process used by NIH. The first level of review provides a judgment of scientific merit. The second level of review (usually conducted by an ICD's advisory Council) assesses the quality of the first review, sets program priorities, and makes funding recommendations.
E-Business Point of Contact (POC)
An E-Business POC for an organization is designated during organization registration with the System for Award Management (SAM) and is the person responsible for the administration and management of grant activities in his/her organization. E-Business POCs give representatives of their organization the privilege to submit grant applications through Grants.gov by designating Authorized Organization Representative (AOR) authority.
Early 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.
A requirement by Congress that a Federal Agency spend a specified amount of money for a stated purpose (e.g. to establish a centers program or conduct a clinical trial).
NIH's electronic invention reporting system. Go to iEdison.
Early Established Investigator
Electronic Research Administration (eRA)
The NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical and behavioral investigators worldwide. Registration is required. Go to eRA.
Electronic Streamlined Non-Competing Award Process (eSNAP)
Electronic submission of a Non-Competing continuation progress report, through the eRA Commons, for an award subject to the SNAP (Streamlined Non-Competing Award Process) provisions. Use of eSNAP is mandatory for SNAP awards (see NOT OD-10-093).
Employer Identification Number
Identification of a business to the U.S. Internal Revenue Service; also known as a Federal tax identification number (TIN). The TIN forms the basis for the Entity Identification Number.
Provides race and ethnicity data for the cumulative number of human subjects enrolled in an NIH-funded clinical research study since the protocol began. This data is provided in competing continuation applications and annual progress reports.
Entity Identification Number (EIN)
A three-part coding scheme of 12 characters used in the Program Management System (PMS) to identify organizations and individuals. The first character identifies the recipient as an organization or an individual. The next nine characters are the Employer Identification Number. The last two characters are a suffix to provide distinction between organizational entities that are assigned a single EIN and those that have more than one.
Tangible personal property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds the lesser of the capitalization level established by the non-Federal entity for financial statement purposes, or $5,000. (See also capital assets, computing devices, general purpose equipment, information technology systems, special purpose equipment, and supplies).
The Electronic Research Administration (eRA) Commons is a virtual meeting place where NIH extramural recipient organizations, recipients, 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.
During the process of submitting a grant application electronically, applicants may receive a notification of errors from the eRA Commons. Errors are critical problems with the application such as significant inaccuracies, inconsistencies or omissions.
Errors stop the application from processing and must be corrected by the submission deadline in order for the application to move forward in the submission process.
Early Stage Investigator
Electronic Streamlined Non-competing Award Process
Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, “Spanish origin,” can be used in addition to “Hispanic or Latino.”
Not Hispanic or Latino
In addition to OMB ethnic and racial categories, each ethnic/racial group contains subpopulations that are delimited by geographic origins, national origins, and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific origins and/or cultural heritage. Attention to subpopulations also applies to individuals who self-identify with more than one race. These ethnic/racial combinations may have biomedical, behavioral, and/or socio-cultural implications related to the scientific question under study.
Excluded Parties List System
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.
An existing dataset may be constructed of different types of data including but not limited to survey data, demographic information, health information, genomic information, etc. Also included would be data to be derived from existing samples of cells, tissues, or other types of materials that may have been previously collected for a different purpose or research question but will now be used to answer a new research question. In general, these will be studies meeting the NIH definition for clinical research with a prospective plan to analyze existing data and/or derive data from an existing resource and where no ongoing or future contact with participants is anticipated.
Expanded Authorities (EA)
Operating authorities provided in Federal Administrative Regulations (e.g., A-110) to recipients 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 NIH Grants Policy Statement: 8 Administrative Requirements 8.1 Changes in Project and Budget 8.1.1 NIH Standard Terms of Award).
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)
(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:
(i) Cash disbursements for direct charges for property and services;
(ii) The amount of indirect expense charged;
(iii) The value of third-party in-kind contributions applied; and
(iv) The amount of cash advance payments and payments made to subrecipients.
(3) For reports prepared on an accrual basis, expenditures are the sum of:
(i) Cash disbursements for direct charges for property and services;
(ii) The amount of indirect expense incurred;
(iii) The value of third-party in-kind contributions applied; and
(iv) The net increase or decrease in the amounts owed by the non-Federal entity for:
(A) Goods and other property received;
(B) Services performed by employees, contractors, sub-recipients, and other payees; and
(C) Programs for which no current services or performance are required such as annuities, insurance claims, or other benefit payments.
In context of awarded grant:
In context of funding opportunity announcement key dates:
Research studies in the early and conceptual stages of development. Exploratory studies may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.
Funds provided by the NIH to researchers and organizations outside the NIH.
Research supported by NIH through a grant, contract, or cooperative agreement.
Facilities and Administrative (F&A) Costs (or indirect costs)
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. (See NIH Grants Policy Statement 7.3 Direct Costs and Facilities and Administrative Costs)
Faculty- or Student-owned Entity
A small business concern (SBC) that is at least 51% owned and controlled by one or more individuals that, at time of application, is either a faculty member or a student of an institution of higher education as defined in 20 U.S.C. §1001.
The simultaneous submission and concurrent review of a combined Phase I/Phase II SBIR or STTR grant application. This option is intended to reduce/eliminate the funding gap between SBIR/STTR Phase I and Phase II projects.
Federal Acquisition Regulations (FAR)
Laws regulating government contracting. Go to FAR.
Federal Advisory Committee Act (FACA)
A law enacted in 1972 to ensure that advice by the various advisory committees formed over the years is objective and accessible to the public.
An "agency' as defined at 5 U.S.C. 551(1) and further clarified by 5 U.S.C. 552(f).
Federal Audit Clearinghouse (FAC)
The clearinghouse designated by OMB as the repository of record where non-Federal entities are required to transmit the reporting packages required by Subpart F-Audit Requirements of 2 CFR 200. The mailing address of the FAC is Federal Audit Clearinghouse, Bureau of the Census, 1201 E. 10th Street, Jeffersonville, IN 47132 and the web address is: http://harvester.census.gov/sac/. Any future updates to the location of the FAC may be found at the OMB Web site.
Depending on the context, in either paragraph (1) or (2) of this section:
Federal Award Date
The date when the Federal award is signed by the authorized official of the Federal awarding agency.
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 Awarding Agency
The Federal agency that provides a Federal award directly to another entity. See also Awarding IC.
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:
(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:
(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 Funding Accountability and Transparency Act (Transparency Act)
See Transparency Act.
A Cabinet-level department or independent agency of the executive branch of the Federal government or any component organization of such a department or agency. For the purposes of this document, this term is used in the context of a Federal institution as a recipient. See also Awarding IC.
For purposes 45 CFR 75.343 or when used in connection with the acquisition or improvement of real property, equipment, or supplies under a Federal award, the dollar amount that is the product of the: (1) Federal share of total project costs; and (2) Current fair market value of the property, improvements, or both, to the extent the costs of acquiring or improving the property were included as project costs.
(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.
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.
The portion of the total project costs that are paid by Federal funds.
Federal Technology Transfer Act (FTTA)
Authorizes Government Agencies to enter into CRADAs with private companies.
Federal-Wide Assurance (FWA)
The Federal-Wide 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 NIH Grants Policy Statement: 18 Grants to For-Profit Organizations 18.5 Small Business Innovation Research and Small Business Technology Transfer Programs 18.5.4 Allowable Costs and Fee 188.8.131.52 Profit or Fee).
An NIH training program award where the NIH specifies the individual receiving the award. Fellowships comprise the F activity codes.
Final Peer-reviewed Manuscript
The author's final manuscript of a peer-reviewed article accepted for journal publication, including all modifications from the peer review process.
Final Proposal Revision (FPR)
After completion of negotiations, offerors are asked to submit a final proposal revision which documents all cost and technical agreements reached during negotiations.
Final Published Article
The journal's authoritative copy of the article, including all modifications from the publishing peer review process, copyediting and stylistic edits, and formatting changes.
Transfer by NIH of money or property to an eligible entity to support or stimulate a public purpose authorized by statute.
Financial Conflict of Interest
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.
Financial Status Report (FSR)
A financial report due 90 days after the end of each budget period for those awards not under SNAP, and at the end of the competitive segment for those awards under SNAP, showing the status of awarded funds for that period. The report is mandatory for continued funding of the grant. The form numbers for FSRs are SF 269 and SF 269A. Note the FSR has been replaced with the FFR (SF425).
Financial Status Report (FSR) Role
In the NIH Commons, allows members of your staff to process Financial Status Reports (FSRs) for submission to the NIH electronically. An account with only the FSR Role assigned can perform FSR tasks. An account can include multiple roles, including that of FSR.
Any of 235 research areas reported by the central NIH Office of Budget and through the public NIH Report website. Categories may refer to research, conditions, diseases or crosscutting areas and break down the NIH funding for reporting purposes. Also known as reporting category.
Fiscal Year (FY)
The annual period established for Government accounting purposes. A Fiscal Year begins on October 1 and ends September 30 of the following year. Example: FY2011-Started October 1, 2010 and ends September 30, 2011.
An organization, institution, corporation, or other legal entity that is organized or operated for the profit or financial benefit of its shareholders or other owners. A for-profit organization is considered to be a small business if it is independently owned and operated, if it is not dominant in the field in which research is proposed, and if it employs no more than 500 persons. (Also see definition for small business concern.)
The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient 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 recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient 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:
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.
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.
Foreign Public Entity
(1) A foreign government or foreign governmental entity; (2) A public international organization, which is an organization entitled to enjoy privileges, exemptions, and immunities as an international organization under the International Organizations Immunities Act (22 U.S.C. 288-288f); (3) An entity owned (in whole or in part) or controlled by a foreign government; or (4) Any other entity consisting wholly or partially of one or more foreign governments or foreign governmental entities.
A 'form' is a named collection of data fields approved by the Office of Management and Budget (OMB).
Freedom of Information Act (FOIA)
Requires dissemination, upon request, of Government documents while ensuring protection of proprietary and other privacy act information. Go to FOIA.
The number of days per week and/or months per year representing full-time effort at the applicant/recipient organization, as specified in organizational policy. The organization's policy must be applied consistently regardless of the source of support.
Funding Opportunity Announcement (FOA)
A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts.
Percentage of applicants that receive funding in a fiscal year.
See Fiscal Year
Human subject term indicating a classification of research subjects into women and men.
General Purpose Equipment
Equipment which is not limited to research, medical, scientific or other technical activities. Examples include office equipment and furnishings, modular offices, telephone networks, information technology equipment and systems, air conditioning equipment, reproduction and printing equipment, and motor vehicles. See also "Equipment" and "Special Purpose Equipment."
Generally Acceptable Accounting Principles (GAAP)
The meaning specified in accounting standards issued by the Government Accounting Standards Board (GASB) and the Financial Accounting Standards Board (FASB).
Generally Accepted Government Auditing Standards (GAGAS)
Also known as the Yellow Book, generally accepted government auditing standards issued by the Comptroller General of the United States, which are applicable to financial audits.
Government Accountability Office (GAO)
An oversight organization reporting to Congress. Go to GAO.
Government Printing Office (GPO)
Produces and distributes Federal Government information products. Go to GPO.
In the context of NIH’s R15 program, a graduate school offers advanced degrees, beyond the undergraduate level, in an academic discipline. Advance degrees include M.A., M.S., and Ph.D.
Financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
A DHHS policy providing for an appeal by the grantee institution of post award administrative decisions made by awarding offices. The two levels of appeal are an informal NIH procedure and a formal DHHS procedure. The grantee must first exhaust the informal procedures before appealing to the DHHS Appeals Board. (See Grant Appeals Procedures in the NIHGPS.)
Grant Compliance Review
An evaluation by grants management staff to assess an institution's business and financial management systems to ensure that regulations and policies are being followed.
Sample Grant Number 1 R01 AI 183723 -01 A1 S1
Grant or Grant 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, 6304:
Grant Start Date
Official date a grant award begins; same as the first day of the first budget period.
Grant-Supported Project or Activity
Those activities specified or described in a grant application or in a subsequent submission that are approved by an NIH IC for funding, regardless of whether Federal funding constitutes all or only a portion of the financial support necessary to carry them out.
Grants Management Officer (GMO)
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.
Grants Management Specialist (GMS)
A NIH staff member who oversees the business and other non-programmatic aspects of one or more grants and/or cooperative agreements. These activities include, but are not limited to, evaluating grant applications for administrative content and compliance with statutes, regulations, and guidelines; negotiating grants; providing consultation and technical assistance to grantees; and administering grants after award.
Go to Grants Process Overview.
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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. It is administered and enforced by the Office for Civil Rights, HHS. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. Decisions about applicability and implementation of the Privacy Rule reside with the researcher and the grantee organization. (See HIPAA Privacy Rule.)
Health Professional School or College
In the context of NIH’s R15 program, health professional schools and colleges are accredited institutions that provide education and training leading to a health professional degree, including but not limited to: BSN, MSN, DNP, MD, DDS, DO, PharmD, DVM, OD, DPT, DC, ND, DPM, MOT, OTD, DPT, BME, MSEE, MS-SLP, CScD, SLPD, AuD, MSPO, MSAT, and MPH. Eligible health professional schools/colleges may include schools or colleges of nursing, medicine, dentistry, osteopathy, pharmacy, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy, podiatry, rehabilitation medicine, physical therapy, orthotics & prosthetics, kinesiology, biomedical engineering, occupational therapy and psychology. Accreditation must be provided by a body approved for such purpose by the Secretary of Education.
Health-Related Biomedical or Behavioral Outcome
As related to the definition of a clinical trial, the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects' biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
For purposes of the SBIR/STTR programs, hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
Health and Human Services Acquisition Regulation
High Risk/High Impact (HR/HI)
A category of applications identified by a scientific review group as having a high degree of uncertainty in approach but also a high potential for impact. NIH tracks how many of these applications are identified and funded.
Historically Black College or University (HBCU)
Any historically black college or university established prior to 1964 whose principal mission was and is the education of black Americans, and is accredited by a nationally recognized accrediting Agency or Association determined by the Secretary [of Education] to be a reliable authority as to the quality of training offered or is, according to such an Agency or Association, making reasonable progress toward accreditation.
Historically Underutilized Zone (HUBZone)
A small business concern meeting the following criteria:
2. Owned and controlled by one or more U.S. Citizens.
A facility licensed as a hospital under the law of any state or a facility operated as a hospital by the United States, a state, or a subdivision of a state. Also includes a non-profit or for-profit hospital or a medical care provider component of a non-profit organization (for example, a foundation).
Hispanic Serving Institution
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).
Human Subjects Assurance
A document filed by an institution conducting research on human subjects with the Office for Human Research Protections--HHS which formalizes its commitment to protect the human subjects prior to receiving any HHS grant funding.
Interagency Edison (iEdison) allows government grantees and contractors to report government-funded inventions, patents, and utilization data to the government agency that made the award, as required by the federal Bayh-Dole Act, its implementing regulations, and any related funding agreement terms and conditions.
Information for Management, Planning, Analysis, and Coordination
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).
(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.
Independent Clinical Trial
An independent clinical trial is one for which the researcher proposing the study has primary or lead responsibility for conducting and executing the trial. NIH policy permits individual career development awardees and individuals appointed to institutional career development awards to be involved in a range of clinical trial activities, including leading independent clinical trials. For NRSA trainees or fellows, however, NIH policy precludes leading an independent clinical trial as part of their training experience. Instead, NRSA trainees and fellows interested in clinical trials may gain clinical trial research experience by working on a trial led by their mentor or another investigator.
Indian tribe (or federally recognized Indian tribe)
Any Indian tribe, band, nation, or other organized group or community, including any Alaska Native village or regional or village corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act (43 U.S.C. Chapter 33), which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians (25 U.S.C. 450b (e)). See annually published Bureau of Indian Affairs list of Indian Entities Recognized and Eligible to Receive Services.
Individual Ruth L. Kirschstein NRSA
Information Technology Systems
Computing devices, ancillary equipment, software, firmware, and similar procedures, services (including support services), and related resources. See also computing devices and equipment.
Person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research or undergo a medical procedure.
In giving informed consent, people may not waive legal rights or release or appear to release an investigator or sponsor from liability for negligence. Go to 21 CFR 50.20 and 50.25
A request for applications (RFA), request for proposals (RFP), or program announcement (PA) stating the Institute or Center's interest in receiving research applications in a given area because of a programmatic need or scientific opportunity. RFAs and RFPs generally have monies set aside to fund the applications responding to them; program announcements generally do not.
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.
Institute or Center (IC)
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.
Public or Private entity, including Government Agencies.
Institutional Animal Care & Use Committee (IACUC)
The PHS Policy on Humane Care and Use of Laboratory Animals incorporates the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training, and requires the grantee to maintain an animal care and use program based on the Guide for the Care and Use of Laboratory Animals. An Institutional Animal Care and Use Committee (IACUC) appointed by the Chief Executive Officer or designee, is federally mandated to oversee the institution's animal program, facilities, and procedures (Public Law 99-158, Sec. 495). IACUC review and approval is required for all PHS supported activities involving live vertebrate animals prior to funding.
Institutional Base Salary
The annual compensation paid by an organization for an employee's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual is permitted to earn outside of duties for the applicant/grantee organization. Base salary may not be increased as a result of replacing organizational salary funds with NIH grant funds. Go to Section 7.9.1 Allowability of Costs/Activities-Selected Items of Cost-Salaries and Wages.
Institutional Business Official
Person working in a research organization's business office who has signature or other authority. That person is the same as Grants.gov's Authorized Organizational Representative (AOR) and the eRA Commons' Signing Official (SO).
Institutional Development Awards (IDeA)
Institutional Development Awards (IDeA) enhance biomedical and behavioral research in specific geographic areas. The Division of Research Infrastructure of the National Center for Research Resources (NCRR) provides IDeA grants to foster research within states that traditionally have not received significant levels of competitive funding from the National Institutes of Health (NIH).
Institutional Review Board (IRB)
An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated. The Institutional Review Board has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.
Institutional Ruth L. Kirschstein NRSA
Institutions of Higher Education (IHEs)
IHE is defined at 20 U.S.C. 1001.
Property having no physical existence, such as trademarks, copyrights, patents and patent applications and property, such as loans, notes and other debt instruments, lease agreements, stock and other instruments of property ownership (whether the property is tangible or intangible).
Integrated Review Group (IRG)
A cluster of scientifically related Study Sections. Applications reviewed by the Center for Scientific Review are often initially assigned at the IRG level and then subsequently assigned to a specific Study Section or Special Emphasis Panel. This two-stage process assignment process provides the opportunity to gain a broad perspective of the areas of science covered by the IRG and to appreciate changes in emphasis and the emergence of new areas while ensuring each application is reviewed by the most appropriate review group.
Creative works or ideas embodied in a form that can be shared or can enable others to recreate, emulate, or manufacture them. Intellectual property is protected by state and federal laws governing inventions, patents, trademarks, unfair competition, copyrights, trade secrets, data and Technical Data, the right of publicity, and new plant varieties. Examples of intellectual property are: inventions; patents; copyrights; designs; know-how; business, technical, and research methods; and other types of intangible business assets such as goodwill and brand recognition. An SBC’s intellectual property may include what it proposes and/or generates in its participation in the SBIR/STTR programs.
Intergovernmental Personnel Act (IPA)
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 tribe (or "federally recognized Indian tribe" 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.
Internal Control over Compliance Requirements for Federal Awards
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:
(i) Permit the preparation of reliable financial statements and Federal reports;
(ii) Maintain accountability over assets; and
(iii) Demonstrate compliance with Federal statutes, regulations, and the terms and conditions of the Federal award;
(2) Transactions are executed in compliance with:
(i) 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
(ii) 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.
A process, implemented by a non-Federal entity, designed to provide reasonable assurance regarding the achievement of objectives in the following categories: (1) Effectiveness and efficiency of operations; (2) Reliability of reporting for internal and external use; and (3) Compliance with applicable laws and regulations.
An organization that identifies itself as international or intergovernmental, and has membership from, and represents the interests of, more than one country, without regard to whether the headquarters of the organization and location of the activity are inside or outside of the United States.
Internet Assisted Review (IAR)
Allows reviewer to submit critiques and preliminary scores for applications they are reviewing. Allows Reviewers, SRAs, and GTAs to view all critiques in preparation for a meeting. IAR creates a preliminary summary statement body containing submitted critiques for the SRA or GTA.
As related to the definition of a clinical trial, a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
Research conducted by, or in support of, employees of the NIH.
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.
Investigational New Drug (IND)
A new drug or biological drug that is used in a clinical investigation.
Investigational New Drug Application
Under regulation 21 CFR 312, application filed by a drug sponsor with FDA on Form FDA 1571 to conduct clinical trials, including detailed descriptions of all phases, protocols, IRB members, and investigators. Once clinical evaluation is completed, a new drug application must be submitted to FDA to obtain approval to market the drug.
Research funded as a result of an investigator, on his or her own, submitting a research application. Also known as unsolicited research. Unsolicited applications are reviewed by chartered CSR review committees.
Institutional Profile File (IPF) number is a unique number used by NIH for tracking/reporting awards to grantee institutions.
IRB Reliance (Authorization) Agreement
A formal, written document that details an agreement for an institution engaged in nonexempt human subjects research to rely on the institutional review board (IRB) of another institution.
An association of concerns with interests in any degree or proportion by way of contract, express or implied, consorting to engage in and carry out a single specific business venture for joint profit, for which purpose they combine their efforts, property, money, skill, or knowledge, but not on a continuing or permanent basis for conducting business generally. A joint venture is viewed as a business entity in determining power to control its management. See 13 C.F.R. §121.103(h).
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.
Key Biological and/or Chemical Resources
Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics.
See Senior/Key Personnel.
Letter of Intent
Some ICs request prospective applicants to submit letters of intent prior to the submission of a grant application. The letter usually includes the name, address and phone number of the PI, identifies other key personnel and participating institutions, and the RFA or PA identification. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows institute staff to estimate the potential review workload and plan for the application.
LikeThis is a new search tool to aid Principal Investigators in finding and learning about other research projects that have similar goals and objectives as their own. By entering specific scientific terms or accessing their own grant applications or grants and clicking on LikeThis, investigators will be provided a listing of similar funded projects and/or publications.
See the LikeThis Overview.
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.
Any unit of government within a state, including a: (1) County; (2) Borough; (3) Municipality; (4) City; (5) Town; (6) Township; (7) Parish; (8) Local public authority, including any public housing agency under the United States Housing Act of 1937; (9) Special district; (10) School district; (11) Intrastate district; (12) Council of governments, whether or not incorporated as a nonprofit corporation under state law; and (13) Any other agency or instrumentality of a multi-, regional, or intra-state or local government.
See Letter of Intent
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.
For purposes of the SBIR/STTR programs, “market research” is defined as the systematic gathering, editing, recording, computing, and analyzing of data about problems related to the sale and distribution of the subject of the research project. It includes various types of research, such as the size of potential market and potential sales volume, the identification of consumers most apt to purchase the product(s), and the advertising media most likely to stimulate their purchases. However, “market research” does NOT include activities under a research plan or protocol that require a survey of the public as part of the objective of the project to determine the impact of the subject of the research on the behavior of individuals.
Matching or Cost Sharing
The portion of project costs not paid by Federal funds (unless otherwise authorized by Federal statute). This may include the value of allowable third party in-kind contributions, as well as expenditures by the recipient.
Material Transfer Agreement (MTA)
A legal document defining the conditions under which research or other materials can be transferred and used among research laboratories.
Extramural research awards are divided into three main funding mechanisms: grants, cooperative agreements and contracts. A funding mechanism is the type of funded application or transaction used at the NIH. Within each funding mechanism NIH includes programs. Programs can be further refined by specific activity codes.
A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A mechanistic study may be classified as a clinical trial if the study meets the NIH definition of a clinical trial.
Medical Scientist Training Program (MSTP)
The Medical Scientist Training Program (MSTP) supports the integrated medical (or equivalent professional clinical) degree and graduate research training required for the investigation of human diseases. MSTP assures highly selected trainees a choice of a wide range of pertinent graduate programs in the biological, chemical, and physical sciences which, when combined with training in medicine, lead to the M.D.-Ph.D. degree.
National Library of Medicine's database for scientific publications. See PubMed.
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.
A purchase of supplies or services using simplified acquisition procedures, the aggregate amount of which does not exceed the micro-purchase threshold. Micro-purchase procedures comprise a subset of a non-Federal entity's small purchase procedures. The non-Federal entity uses such procedures in order to expedite the completion of its lowest-dollar small purchase transactions and minimize the associated administrative burden and cost. The micro-purchase threshold is set by the Federal Acquisition Regulation at 48 CFR Subpart 2.1 (Definitions). It is $3,000 except as otherwise discussed in Subpart 2.1 of that regulation, but this threshold is periodically adjusted for inflation.
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.
Minority Access to Research Careers (MARC)
A National Research Service Award (NRSA) program to enhance diversity in the biomedical research workforce. The various MARC programs provide undergraduates with research training opportunities in the biomedical sciences.
Minority Biomedical Research Support (MBRS)
A program to strengthen the biomedical research and research training capability of ethnic minority institutions. The intent is to increase the involvement of minority faculty and students in biomedical research.
Animal, plant, or other organism used to study basic biologic processes to provide insight into other organisms. See Model Organism Sharing. Go to NIH's Model Organism for Biomedical Research.
Model Organism Sharing
Policy stating a PD/PI applicant must submit plans for sharing mammalian and non-mammalian eukaryotic models to comply with the NIH Policy on Sharing of Model Organisms. Go to NIH's Model Organisms for Biomedical Research.
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.
Modified Summary Statement
Former term for a summary statement containing reviewer critiques, which is now standard practice. See Summary Statement.
Modified Total Direct Cost (MTDC)
Modified Total Direct Cost (MTDC) means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $25,000 of each subaward (regardless of the period of performance of the subawards under the award). MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward in excess of $25,000. Other items may only be excluded when necessary to avoid a serious inequity in the distribution of indirect costs, and with the approval of the cognizant agency for indirect costs.
A type of grant application in which support is requested in specified increments without the need for detailed supporting information related to separate budget categories. When modular procedures apply, they affect not only application preparation but also review, award, and post-award administration. Go to Modular.
A process whereby the programmatic and business management performance aspects of a grant are assessed by reviewing information gathered from various required reports, audits, site visits, and other sources.
Memorandum of Understanding
Multi-project Grant Application
A multi-project application is a single grant application submission with multiple, interrelated components with defined work, personnel,sites and budgets that share a common focus or objective.
Multi-Year Funding (MYF)
Multi-year funded (MYF) awards are where the project period and budget period are the same and are longer than one year. A no-cost extension of an existing grant does not constitute Multi-Year Funding.
Multiple Program Director/Principal Investigator
Multiple Program Director/Principal Investigator (multiple PD/PI) awards are an opportunity for multidisciplinary efforts and collaboration through a team of scientists under a single grant award. All PD/PIs share equally the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant organization, or as appropriate to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. Go to Multiple Principal Investigators.
National Advisory Council
An action whereby the name of an organization is changed without otherwise affecting the rights and obligations of that organization as a recipient.
National Institutes of Health (NIH)
A Federal agency whose mission is to improve the health of the people of the United States. NIH is a part of the Public Health Service, which is part of the U.S. Department of Health and Human Services. Go to NIH.
National Library of Medicine (NLM)
The National Library of Medicine (NLM), on the campus of the National Institutes of Health in Bethesda, Maryland, has been a center of information innovation since its founding in 1836. The world's largest biomedical library, NLM maintains and makes available a vast print collection and produces electronic information resources on a wide range of topics that are searched billions of times each year by millions of people around the globe.
As part of the Public Access policy, in Spring, 2013, at the earliest, NIH will delay processing of non-competing continuation grant awards if publications arising from that award are not in compliance with the NIH public access policy. Compliant publications must be registered on NLM via MyNCBI.
See Guide Notice NOT-OD-12-160.
National Research Service Award (NRSA)
National Center for Complementary and Alternative Medicine (dissolved 12/2014)
National Center for Complementary and Integrative Health (formally NCCAM)
NIH National Center for Research Resources (dissolved 12/2011)
NIH Enterprise Directory
New Application (award, grant)
Refers to an application not previously proposed, or one that has not received prior funding. Also known as a Type 1.
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. The list of NIH grants that a PD/PI can hold and still be considered a New Investigator is the same as the list of grants that a PD/PI can hold and still be considered an Early Stage Investigator. This list can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm.
NIH Director's Pioneer Award
The NIH Director's Pioneer Award supports individual scientists of exceptional creativity who propose pioneering approaches to major challenges in biomedical and behavioral research. The term "pioneering" is used to describe highly innovative - potentially transformative - approaches having the potential to produce an unusually high impact, and the term "award" is used to mean a grant for conducting research, rather than a reward for past achievements. Biomedical and behavioral research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences. Go to NIH Director's Pioneer Award.
NIH Grants Policy Statement (NIHGPS)
A consolidated resource of policy requirements that serve as the terms and conditions of NIH grant awards. It also provides general information about NIH-its organization, staff, and grants process. Current and historical versions of the NIHGPS can be found on the OER Grants Policy and Guidance webpage.
NIH Guide for Grants and Contracts
The official publication for NIH's medical and behavioral research grants policies, guidelines and funding opportunities. Go to Funding Opportunities and Notices.
NIH-Defined Phase III Clinical Trial
An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
National Institutes of Health, Office of the Director
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.
Non-Competing Continuation Application/Award
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.
A state, local government, Indian tribe, institution of higher education (IHE), or nonprofit organization that carries out a Federal award as a recipient or subrecipient.
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, not including IHEs, that: (1) Is operated primarily for scientific, educational, service, charitable, or similar purposes in the public interest; (2) Is not organized primarily for profit; and (3) Uses net proceeds to maintain, improve, or expand the operations of the organization.
Not Recommended for Further Consideration (NRFC)
An application may be designated Not Recommended for Further Consideration (NRFC) by the Scientific Review Group if it lacks significant and substantial merit; presents serious ethical problems in the protection of human subjects from research risks; or presents serious ethical problems in the use of vertebrate animals, biohazards, and/or select agents. Applications designated as NRFC do not proceed to the second level of peer review (National Advisory Council/Board) because they cannot be funded.
A Notice (Guide Notice) is an official NIH announcement relating to a change in policy, procedure, form, or system. Notices are posted on the NIH website and users can be notified via a variety of NIH listservs. You can search for notices and funding opportunities at the NIH Guide.
Notice of Award (NoA)
The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that:
A process that involves the thorough and consistent examination of applications based on an unbiased evaluation of scientific or technical merit or other relevant aspects of the proposal. The review is performed by persons expert in the field of endeavor for which support is requested, and is intended to provide advice to the individuals responsible for making award decisions.
The amounts for which the recipient has made binding commitments for orders placed for property and services, contracts and subawards, and similar transactions during a funding period that will require payment during the same or a future period.
When used in connection with a non- Federal entity's utilization of funds under a Federal award, obligations means orders placed for property and services, contracts and subawards made, and similar transactions during a given period that require payment by the non- Federal entity during the same or a future period.
A contracting term denoting an applicant responding to a Request for Proposal (RFP).
Office for Human Research Protections (OHRP)
HHS office overseeing human subject protection for HHS-supported research. Go to OHRP.
Office of Extramural Research (OER)
The Office of Extramural Research, housed in the NIH Office of the Director, provides the corporate framework for the NIH research administration and works to ensure the scientific integrity, public accountability, and effective stewardship of the NIH research grant portfolio. Go to OER.
Office of Laboratory Animal Welfare (OLAW)
NIH office overseeing compliance with the PHS Policy on Humane Care and Use of Laboratory Animals. Go to OLAW and PHS Policy Tutorial.
Office of Management and Budget (OMB)
The Executive Office of the President, Office of Management and Budget.
Office of Research Information Systems (ORIS)
Provides IT systems, data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans' Administration) and works with the user community to provide efficient techniques for the conduct of extramural business. An office in the Office of Extramural Research, Office of the Director, NIH. The electronic Research Administration (eRA) and the Division of Information Services are part of ORIS.
Office of Research Integrity (ORI)
HHS office promoting integrity in biomedical and behavioral research supported by the Public Health Service by monitoring institutional investigations of scientific misconduct and facilitating the responsible conduct of research. Go to ORI.
For the purposes of the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects, an older adult is defined as an individual 65 years of age or older. The intent of the NIH policy is to provide the opportunity for individuals, including children and older adults, to participate in research studies when there is a sound scientific rationale for including them, and their participation is appropriate. Thus, older adults must be included in NIH-conducted or supported human subjects research unless there are scientific or ethical reasons not to include them.
Government-wide guidance issued to Heads of Federal agencies by the Director of OMB. OMB Circulars directly pertinent to grants include the following:
Some (but not all) of these OMB Circulars were reissued in Title 2 of the Code of Federal Regulations (CFR). Effective December 26, 2014, these Circulars were superseded by OMB's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards ("Uniform Guidance") located in 2 CFR Part 200.
For an application to be considered on-time, all registrations must be completed and an error free application must be submitted to and accepted by Grants.gov with a timestamp on or before 5:00 p.m. local time of submitting organization on submission deadline date.
First date an applicant can submit an electronic grant application to NIH through Grants.gov. NIH typically allows applications to be submitted up to 30 days in advance of a submission deadline.
A generic term used to refer to an Institution of Higher Education or other entity, including an individual, which applies for or receives an NIH grant or cooperative agreement.
A two-letter code in the grant number identifying the first major-level subdivision of the funding organization.
Other Research Grants
Grants to institutions to provide developmental opportunities for investigators at various stages of their biomedical research careers. The programs are Research Careers, Cancer Education Cooperative Clinical Research, Biomedical Research Support, Minority Biomedical Research Support, and Other areas of research.
Other Significant Contributors (OSCs)
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. Learn more about Other Support.
'Overall' is a special component type within a multi-project grant application, used by the applicant organization, with a single occurrence in every multi-project application. The Overall component typically contains information about the application as a whole and how the various other components fit together.
Overlap of Support
Other support duplicating research or budgetary items already funded by an NIH grant. Overlap also occurs when any project-supported personnel has time commitments exceeding 12 person months. See Scientific Overlap.
Oversight Agency for Audit
The Federal awarding agency that provides the predominant amount of funding directly to a non-Federal entity not assigned a cognizant agency for audit. When there is no direct funding, the Federal awarding agency which is the predominant source of pass-through funding must assume the oversight responsibilities. The duties of the oversight agency for audit and the process for any reassignments are described in 2 CFR 75.513(b).
See Program Announcement.
Learn more about types of funding opportunity announcements .
Participant Support Costs
Direct costs for items such as stipends or subsistence allowances, travel allowances, and registration fees paid to or on behalf of participants or trainees (but not employees) in connection with conferences, or training projects. For the purposes of Kirschstein-NRSA programs, this term does not apply. NIH will continue to use the terms trainees, trainee-related expenses, and trainee travel in accordance with NRSA Regulations.
A non-Federal entity that provides a subaward to a subrecipient to carry out part of a Federal program.
Document issued by the U.S. Patent and Trademark Office containing a description, specification, and claims that describe the subject matter in detail and giving its owner a right to exclude others from making, using, or selling it.
Only the inventor can obtain a patent; however, employers often require employees to hand over patent rights.
Requirement that the recipient of a NRSA postdoctoral fellowship engage in qualified research or teaching activities for a length of time equal to the period of NRSA support received. Only the first year of training incurs a payback obligation. In general, payback activity must involve at least 20 hours per week and be conducted over 12 consecutive months; special exceptions may be considered on a case-by-case basis. See Ruth L. Kirschstein National Research Service Awards-Payback for additional information.
A percentile-based funding cutoff point determined by balancing the projected number of applications coming to an NIH Institute with the amount of funds available. Set after the budget is determined, paylines are not mandatory, are not made for all activity codes, and may be adjusted during the year.
For additional information see post on paylines, percentiles and success rates.
Payment Management System (PMS)
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.
Program Classification Code
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.
Peer Review Criteria
Represents the relative position or rank of each impact/priority score (along a 100.0 percentile band) among the scores assigned by a particular study section.
For additional information see post on paylines, percentiles and success rates.
Period of Performance
The time during which the non-Federal entity may incur new obligations to carry out the work authorized under the Federal award. The Federal awarding agency or pass-through entity must include start and end dates of the period of performance in the Federal award.
Permanent Resident Card
Shows a person's status as a permanent resident with a right to live and work permanently in the U.S. Commonly known as a "Green Card." Also called USCIS Form I-551. Go to U.S. Citizenship and Immigration Services.
The metric for expressing the effort (amount of time) PD/PI(s), faculty and other senior/key personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year, academic year, and/or summer term; and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment. See also Frequently Asked Questions Regarding the Usage of Person Months.
Property of any kind except real property. It may be tangible, having physical existence, or intangible, such as copyrights, patents, or securities.
Personally Identifiable Information (PII)
Information that can be used to distinguish or trace an individual's identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. Some information that is considered to be PII is available in public sources such as telephone books, public Web sites, and university listings. This type of information is considered to be Public PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials. The definition of PII is not anchored to any single category of information or technology. Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified. Non-PII can become PII whenever additional information is made publicly available, in any medium and from any source, that, when combined with other available information, could be used to identify an individual.
Phase IIB Competing Renewal
An application requiring competitive peer review and Institute/Center action to continue beyond the SBIR/STTR Phase II award.
PHS Policy on Humane Care and Use of Laboratory Animals
Term and condition of all PHS awards involving live, vertebrate animals.
Planned Enrollment Report
The Planned Enrollment Report is used when you are planning to conduct a study that meets the NIH definition for clinical research. It provides a breakdown of the planned sample by sex/gender, race, and ethnicity.
PubMed Central Reference
Patient Oriented Research
For purposes of the SBIR/STTR programs, portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
An individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his or her chosen career path. (See the NIH-NSF Definition of a Postdoctoral Scholar. (PDF - 85 KB))
Program Project Grant
A statement in summary form of the intent of the applicant to request funds. It is used to determine the applicant's eligibility and how well the project can compete with other applications and eliminate proposals for which there is little or no chance for funding.
Any cost incurred prior to the beginning date of the project period or the initial budget period of a competitive segment (under a multi-year award), in anticipation of the award and at the applicant's own risk, for otherwise allowable costs.
The annual budget request submitted to Congress by the U.S. President. The process begins with a budget request from the Institute or Center, which, as part of the entire NIH budget request, is modified by the Office of Management and Budget.
Presidential Early Career Award for Scientists and Engineers (PECASE)
The Presidential Award is the highest honor bestowed by the U.S. Government on outstanding scientists and engineers beginning their independent careers. Go to PECASE.
Principal Investigator Work in Progress (PIW)
As used in the eRA Commons, PIW is a possible status of an eSNAP (Electronic Streamlined Non-competing Award Process) report. The PIW status (or a different status) would appear in the eSubmission column of the PI List of Applicants/Grants hit list screen.
Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements).
The Privacy Act of 1974, 5 U.S.C. 552a (as amended), and its implementing regulations (45 CFR part 5b) provide certain safeguards for information about individuals maintained in a system of records (i.e., information may be retrieved by the individual's name or other identifying information). These safeguards include the rights of individuals to know what information about them is maintained in Federal agencies' files (hard copy or electronic) and how it is used, how they may obtain access to their records, and how to correct, amend, or request deletion of information in their records that is factually incorrect. Records maintained by NIH with respect to grant applications, grant awards, and the administration of grants are subject to the provisions of the Privacy Act.
Private Equity Firm
For purposes of the SBIR/STTR programs, private equity firm has the meaning given the term “private equity fund” in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
The acquisition of property or services for the direct benefit or use of the Government, generally via a contract.
A coherent assembly of plans, project activities, and supporting resources contained within an administrative framework, the purpose of which is to implement an organization's mission or some specific program-related aspect of that mission. For the NIHGPS, "program" refers to those NIH programs carrying out their missions through the award of grants or cooperative agreements to other organizations.
Program Announcement (PA)
A PA is a formal statement about a new or ongoing extramural activity or program. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or program, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes. NIH may also make funds available through PARs (PAs with special receipt, referral, and/or review considerations) and PASs (PAs with set-aside funds).
PAs may be used for any support mechanism other than construction awards. Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated. PAs also are used to annually solicit applications for the SBIR and STTR programs. Those applications must be received by the dates specified in the PA.Program Announcements (PA) are published in the NIH Guide for Grants and Contracts. Go to Program Announcements. Learn more about types of funding opportunity announcements.
Program Announcement (PAR)
Program Announcement with special receipt, referral and/or review considerations.Learn more about types of funding opportunity announcements.
Program Announcement with Set-Aside Funds (PAS)
Program Announcement with set-aside funds. Learn more about types of funding opportunity announcements.
The need to balance an Institute's support of research in all its programmatic areas with its high-quality applications eligible for funding.
Program Classification Code (PCC)
An internal code unique for each I/C indicating the I/C's scientific interest and used to identify internal programs, branch classifications, the science or disease area, and sometimes program officials.
Program Director/Principal Investigator (PD/PI)
The individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the applicant organization, or as appropriate, to a collaborating organization for the proper conduct of the project or program including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI.
Gross income earned by the non-Federal entity that is directly generated by a supported activity or earned as a result of the Federal award during the period of performance except as provided in 45 CFR 75.307(f). (See Period of performance.) Program income includes but is not limited to income from fees for services performed, the use or rental or real or personal property acquired under Federal awards, the sale of commodities or items fabricated under a Federal award, license fees and royalties on patents and copyrights, and principal and interest on loans made with Federal award funds. Interest earned on advances of Federal funds is not program income. Except as otherwise provided in Federal statutes, regulations, or the terms and conditions of the Federal award, program income does not include rebates, credits, discounts, and interest earned on any of them. See also 45 CFR 75.307, 45 CFR 75.407 and 35 USC § § 200-212 (applies to inventions made under Federal awards). (See Administrative Requirements-Management Systems and Procedures-Program Income).
Program Official (PO)/Program Officer/Project Officer
The NIH official responsible for the programmatic, scientific, and/or technical aspects of a grant.
The dollar amount a grant award is reduced from the amount recommended by the study section (scientific review group). This is done so Institutes can maintain a sufficient number of grants in their portfolio and to combat inflation of grant costs.
Periodic, usually annual, report submitted by the grantee and used by NIH to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report. This report may also be called the non-competing continuation progress report.
Commonly referred to as the application number or grant number, depending upon its processing status. This unique identification number for the grant is composed of the type code, activity code, Institute code, serial number, support year, and/or suffix code. See also Application Identification Numbers.
Project Performance Site
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 segment(s) resulting from a renewal award(s), and extensions.
Patient-Reported Outcomes Measurement Information Systems
Real property or personal property.
Prospective Basic Science Studies Involving Human Participants
As related to the definition of a clinical trial, a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
Protected Personally Identifiable Information (Protected PII)
An individual's first name or first initial and last name in combination with any one or more of types of information, including, but not limited to, social security number, passport number, credit card numbers, clearances, bank numbers, biometrics, date and place of birth, mother's maiden name, criminal, medical and financial records, educational transcripts. This does not include PII that is required by law to be disclosed. (See also Personally Identifiable Information (PII).
Formal description and design for a specific research project. A protocol involving human subject research must be reviewed and approved by an Institutional Review Board (IRB) if the research is not exempt, and by an IRB or other designated institutional process for exempt research.
A model of something to be further developed and includes designs, protocols, questionnaires, software, and devices.
Public Access Compliance Monitor (PACM)
A web-based tool that institutions can use to track compliance of publications that fall under the NIH Public Access Policy.
Public Access Policy
The NIH policy designed to ensure that the public has access to the published results of NIH-funded research. See http://publicaccess.nih.gov/
Public Health Service (PHS)
Umbrella organization in the U.S. Federal Government consisting of eight HHS health Agencies, the Office of Public Health and Science, and the Commissioned Corps (a uniformed service of more than 6,000 health professionals). The NIH is the largest Agency within the PHS. Go to Office of the Assistant Secretary for Health, HHS.
PubMed provides access to citations from biomedical literature. It includes over 17 million citations from MEDLINE and other life science journals for biomedical articles back to the 1950s, along with links to full text articles and other scientific resources. These citations are indexed with a PMID, a series of numbers
PubMed Central (PMC)
PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal papers. These papers are indexed with a PMCID, a series of numbers preceded by 'PMC'. PMC content is publicly accessible and integrated with other databases. See: http://www.pubmedcentral.nih.gov/.
PubMed Central Reference Number (PMCID)
The reference number assigned to an article or manuscript archived in PubMed Central. The PMCID is the number that must be cited on applications, proposals or reports as part of compliance with the Public Access Policy. See also "Citation ID."
PubMed ID Number (PMID)
The unique number assigned to a PubMed citation for an article published in a journal. This number does NOT indicate compliance with the Public Access Policy.
Research & Development
R01 Equivalent Grant
*R35 MIRA for Early Stage Investigators. Not included is a parallel program tailored for Established Investigators.
**Activity codes no longer active.
As an example, in FY 2016, the collection of R01-equivalent Grants included New Investigator Research Awards (R23), First Independent Research Support and Transition Award (R29), Traditional Research Grant (R01), Method to Extend Research in Time (R37), the NIH Director’s New Innovator Award (DP2) and the Multi-Year Funded Research Project Grant (RF1). In some cases, the competition or use varies depending on the fiscal year. TheNIH Data Book provides a fiscal year snapshot or trends showing NIH funding under these activity codes.
American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliation or community attachment.
Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)
Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”
Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.
Research Business Model
Land, including land improvements, structures, and appurtenances, but not movable machinery and equipment.
Research Enhancement Award Programs
Procedure for contesting the peer review of a grant application. Synonymous with appeal.
Receipt, Referral, and Assignment of Applications
Routing of applications arriving at NIH. The Division of Receipt and Referral (DRR) of CSR is the central receipt point for competing applications. The role of the DRR is to assign each application to a review group that has the expertise to evaluate the scientific and technical merit of the application and to one or more ICs for funding consideration. Information on the assignment of grant applications is accessed through the Commons.
An entity, usually but not limited to non-Federal entities, that receives a Federal award directly from a Federal awarding agency to carry out an activity under a Federal program. The term may also include an Individual. The term recipient does not include subrecipients, except as indicated below. See also Non-Federal entity.
Reference Letter or Letters of Reference
A reference letter (or reference form for individual fellowship programs) are letters of recommendation. Letters must be submitted by the same deadline as the grant application and can be submitted before the application itself, as early as the opening date of the Funding Opportunity Announcement (FOA). See Reference Letter FAQs.
Release Date/Posted Date
Date of publication of a Funding Opportunity Announcement in the NIH Guide for Grants and Contracts and Grants.gov.
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."
Research Portfolio Online Reporting Tools
Request for Application (RFA)
An RFA is a formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, whether cost sharing is required, and the application submission date(s). For cooperative agreements, the RFA will describe the responsibilities and obligations of NIH and awardees as well as joint responsibilities and obligations. Applications submitted in response to an RFA are usually reviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued the RFA.
Learn more about types of funding opportunity announcements .
Request for Proposals (RFP)
Announces that NIH would like to award a contract to meet a specific need, such as the development of an animal model. RFPs have a single application receipt date and are published in the NIH Guide for Grants and Contracts.
Research & Development (R&D)
All research activities, both basic and applied, and all development activities that are performed by HHS award recipients. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. "Research' is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development' is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.
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-Recipient Staff.
Research and Development (R&D) Contract
A funding mechanism by which the NIH procures specific services. These are negotiated contracts which may be funded from intramural or extramural accounts. Excluded are inter/intra-Agency agreements (Y01 and Y02), resource and support contracts (N02), and station support contracts (N03).
Research Career Awards (RCA)
Center grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They support long-term, multi-disciplinary programs of research and development. They may include multiple components, including core facilities and services, subprojects, or linked awards.
Research Facilities Improvement Program (RFIP)
The National Center for Research Resources supports the Research Facilities Improvement Program (RFIP). RFIP grants are provided to public and nonprofit private biomedical institutions to expand, remodel, and renovate or alter existing research and animal facilities or construct new research and animal facilities. Improvements under this program must support basic and/or clinical biomedical and behavioral research, and they may also support research training.
Major extramural research grants awarded to institutions, hospitals, and other research organizations, including small businesses, to support circumscribed research led by investigators, create developmental opportunities, and to provide research related resources under programs such as Research Careers, Research Centers, Research Projects, SBIR/STTRs, and Other Research.
Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results.
Research Patient Care Costs
Costs of routine and ancillary services provided by hospitals to participants in research protocols.
Research Performance Progress Report (RPPR)
Progress reports are required annually to document grantee accomplishments and compliance with terms of award. They describe scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. See http://grants.nih.gov/grants/rppr/
The cohort of grants supported by a given NIH organization.
Research Project Grant (RPG)
An award made to an institution/organization to support discrete, specified, circumscribed projects to be performed by named investigators in areas representing their specific interest and competencies.
Research Project Grants and Cooperative Agreements include the following activity codes:
NIH's most commonly used grant program is the Research Project Grant Program (R01). See Types of Grant Programs.
Research Supplement Programs for Special Populations
An award made to an institution/organization to support discrete, specified, circumscribed projects to be performed by named investigators in areas representing their specific interest and competencies NIH's most commonly used grant program is the Research Project Grant Program (R01). See Types of Grant Programs.
Responsible party is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to refer to the entity or individual who is responsible under FDAAA for registering a clinical trial and submitting clinical trial information to ClinicalTrials.gov.
Special term and condition in a Notice of Award or article in a contract that limits activities and expenditures. It may be lifted or adjusted if the requirements are met.
An unfunded application that has been modified following initial review and resubmitted for new consideration. Before a resubmission application can be submitted, the PD/PI must have received the summary statement from the previous review. A resubmission application may be submitted for new, renewal, or revision applications. NIH allows only one resubmission application. Policies regarding resubmission applications can be found in the application guide. A resubmission has a suffix in its application identification number, e.g., A1.See Resubmission Policy.
The terms Study Section and Review Committee are normally used for continuing Scientific Review Groups in the Center for Scientific Review or NIH Institute, respectively. These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.
Refers to the Center for Scientific Review's thrice yearly initial peer review cycle, from the receipt of applications to the date of the review. See Standard Receipt Dates
As defined in the Federalwide SF424 (R&R): An application that proposes a change in 1) the Federal Government's financial obligations or contingent liability from an existing obligation, or 2) any other change in the terms and conditions of the existing award. Note in general for NIH applicants, #2 would not require the submission of another application. NIH grantees use revision applications to request an increase in support in a current budget period for expansion of the project's approved scope or research protocol. Applicants must apply and undergo peer review. The previous NIH term was "competing supplemental." NOTE: The former NIH term "revision," is now "resubmission". A revision has a suffix in its application identification number; e.g., S1.
Request for Quotes (Contracts)
Roadmap Initiative (RM)
See Common Fund.
The functions a user can perform in a system are based on the role assigned to his or her account.
Review Policy Officer
Ruth L. Kirschstein National Research Service Awards (NRSA)
Awards to both individuals and institutions to provide research training in specified health-related areas. Go to Ruth L. Kirschstein National Research Service Award Research Training Grants and Fellowships.
A legislatively-mandated provision limiting the direct salary (also known as salary or institutional base salary, but excluding any fringe benefits and F&A costs) for individuals working on NIH grants, cooperative agreement awards, and extramural research and development contracts. For current and historical salary cap levels, go to Salary Cap Summary.
System for Award Management
SBIR/STTR Technical Data
All data generated during the performance of an SBIR/STTR award.
SBIR/STTR Technical Data Rights
The rights a small business concern obtains in data generated during the performance of any SBIR/STTR Phase I, Phase II, or Phase III award that an awardee delivers to the Government during or upon completion of a Federally-funded project, and to which the Government receives a license.
Science Experts Network (SciENcv)
This new electronic system will enable researchers to easily assemble the information (including expertise, employment, education and professional accomplishments) to populate an NIH biographical sketch (biosketch). (Beta Version available Sept. 2013 – See NIH Guide Notice NOT-OD-13-114)
Overlap of support occurs when substantially similar research is proposed in more than one concurrent PHS grant application.
Scientific Review Group (SRG)
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).
Scientific Review Officer (SRO)
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 strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. This includes full transparency in reporting experimental details so that others may reproduce and extend the findings.
Scope of Work
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.
Scored Review Criteria
For research grant applications, and most other types of applications, reviewers judge the overall impact to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, taking into account five criteria, among other pertinent factors: Significance, Investigator(s), Innovation, Approach, and Environment. These scored review criteria may not be applicable for some types of applications. When these criteria are not applicable, the FOA will include the specific review criteria. Reviewers will consider each of the five criteria in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. See Peer Review Process/Scoring for additional information.
Biological agent or toxin listed in 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121, or the HHS and USDA Select Agents and Toxins List.
Investigators who possess or use a select agent must register with and get approval from either the CDC Select Agent Program or USDA APHIS Agricultural Select Agent Program, depending on the agent.
The funding of a small number of programmatically important applications at the margin of the payline as recommended by Council.
The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as Senior/Key Personnel.
A Service Provider is a commercial company that assists applicants, for a fee, in submitting grant applications electronically through Grants.gov to NIH and other federal agencies. See Service Providers.
Money taken out of the budget for a specific purpose, for example, to fund a congressionally mandated program.
Refers to the classification of research subjects into two categories: male and female. In some cases, representation is unknown, because sex/gender composition cannot be accurately determined (e.g., pooled blood samples or stored specimens without sex/gender designation). In addition, sex/gender classification is based on the self-reporting of participants enrolled in the research study. Investigators should consider the scientific goals of their study when requesting this information particularly if the research may include individuals whose gender identity differs from their sex assigned at birth.
Actions contributing to sexual harassment include unwelcome sexual advances, requests for sexual favors and other verbal or physical conduct of a sexual nature. Harassment does not have to be of a sexual nature. Sexual harassment can be committed by anyone — men or women, against men or women, and by a supervisor, co-worker, subordinate, or non-employee.
In Education, sexual harassment is actionable under Title IX when it is so severe, pervasive, and objectively offensive, that it undermines and detracts from the victims’ educational experience, such that the victims are effectively denied equal access to an institution’s resources and opportunities.*
In Employment, sexual harassment is unlawful when it is so severe and pervasive that a reasonable person would consider it a hostile or intimidating work environment or when enduring the offensive conduct becomes a condition of continued employment.
*Davis v. Monroe County Board of Education, 526 U.S. 629, 649 (1999).
Sharing Model Organisms
Special Interest Category
For purposes of NIH policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.
A threshold that is reached when expenditures in a single direct cost budget category deviate (increase or decrease) from the categorical commitment level established for the budget period by more than 25 percent of the total costs awarded. Significant re-budgeting is one indicator of change in scope.
Signing Official (SO)
A Signing Official (SO) has institutional authority to legally bind the institution in grants administration matters. The individual fulfilling this role may have any number of titles in the grantee organization. The label, "Signing Official," is used in conjunction with the NIH eRA Commons. The SO can register the institution, and create and modify the institutional profile and user accounts. The SO also can view all grants within the institution, including status and award information. An SO can create additional SO accounts as well as accounts with any other role or combination of roles. For most institutions, the Signing Official (SO) is located in its Office of Sponsored Research or equivalent.
Simplified Acquisition Threshold
The dollar amount below which a non-Federal entity may purchase property or services using small purchase methods. Non-Federal entities adopt small purchase procedures in order to expedite the purchase of items costing less than the simplified acquisition threshold. The simplified acquisition threshold is set by the Federal Acquisition Regulation at 48 CFR Subpart 2.1 and in accordance with 41 USC § 1908. (See also Micro-purchase).
Small Business Concern
A business that is independently owned and operated and not dominant in its field of operation; has its principal place of business in the United States and is organized for profit; is at least 51 percent owned, or in the case of a publicly owned business, at least 51 percent of its voting stock is owned by U.S. citizens or lawfully admitted permanent resident aliens; has, including its affiliates, not more than 500 employees; and meets other regulatory requirements established by the Small Business Administration at 13 Code of Federal Regulations (CFR) Part 121.
Small Business Innovation Research (SBIR)
A program designed to support small business concerns conducting innovative research/research & development with potential for commercialization. For the computation of success rates, SBIR awards are not included in the count of RPGs. Go to Small Business Funding Opportunities.
Small Business Technology Transfer (STTR)
A program designed to support cooperative research/research & development with potential for commercialization, through a formal cooperative effort between a small business and a U.S. research institution. For the computation of success rates, STTR awards are not included in the count of RPGs. Go to Small Business Funding Opportunities.
A contracting term denoting the review process by which a contractor is selected.
Special Emphasis Panel (SEP)
Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.
Special Purpose Equipment
Equipment which is used only for research, medical, scientific, or other technical activities. Examples of special purpose equipment include microscopes, x-ray machines, surgical instruments, and spectrometers. See also Equipment and General purpose equipment.
A component of an application's Research Plan which describes concisely the goals of the proposed research and summarizes the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.. Includes the specific objectives of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology).
One or more designated individual(s) responsible for providing the fellow with research training and career guidance throughout the grant award period.
Institution legally responsible for committing facilities for the Kirschstein-NRSA Individual Fellowship applicant and financially responsible for the use and disposition of fellowship funds.
Standard Form 424 (Research & Related) [SF424 (R&R)]
The application data set used by NIH for the electronic submission of grant applications through Grants.gov to NIH. The data set is owned and maintained by Grants.gov and includes both federal-wide and agency-specific forms.
The SF424 (R&R) forms used to submit a grant application to NIH are posted with the specific funding opportunity announcement to which you want to apply. Application guides and format pages used in conjunction with the SF424 (R&R) forms can be found at: http://grants.nih.gov/grants/forms/new-renewal-revisions.htm.
Any state of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and any agency or instrumentality thereof exclusive of local governments.
The Government of any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, any U.S. territory or possession, or any A gency or instrumentality of a State exclusive of local Governments. For purposes of NIH grants, federally recognized Indian Tribal Governments generally are considered State Governments. State institutions of higher education and State hospitals are not considered State Governments for HHS's general administrative requirements for grants and the NIHGPS.
Statement of Work (SOW)
In a contract proposal, the detailed description of the work to be performed under the contract.
Allows Principal Investigators to review the current status of all their grant applications and review detailed information associated with their grants. Institution Officials [i.e., Signing Official (SO) or Administrative Official (AO) associated with the institution] can see a summary view of grant applications, review the Notice of Grant Award, and access the Progress Report face page.
A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee.
Streamlined Non-Competing Award Process (SNAP)
Streamlined process that includes a number of provisions that modify annual progress reports, NoAs, and financial reports. Funds are automatically carried over and are available for expenditure during the entire project period. All NIH award notices identify whether the grant is subject to or excluded from SNAP.
In the peer review process, applications not considered by the Scientific Review Group to be in the more meritorious half are 'streamlined' and designated Not Discussed. Streamlined applications are not discussed at the review meeting and will not be assigned a numerical overall impact/priority score, but the applicants do receive the reviewers' critiques. Streamlined applications will receive criterion scores from the assigned reviewers in addition to the reviewers' critiques to help applicants assess whether or not they should submit a resubmission application.
A research protocol or set of experiments designed to investigate a scientific question.
The definition of a clinical study for the purposes of registering and reporting in ClinicalTrials.gov, can be found here.
A set of data elements about a research investigation involving human subjects that describes a proposed or on-going study, most commonly used in the context of the PHS Human Subjects and Clinical Trials Information form.
Note that for the purposes of initial application, NIH supports grouping studies that use the same human subjects population and same research protocols , the same research procedures, and the same human subjects population into a single study record, to the extent that the information provided is accurate and understandable to NIH staff and reviewers.
The terms Study Section and Review Committee are normally used for continuing Scientific Review Groups in the Center for Scientific Review or NIH Institute, respectively. These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.
An award provided by a pass-through entity to a subrecipient for the subrecipient to carry out part of a Federal award received by the pass-through entity. It does not include payments to a contractor or payments to an individual that is a beneficiary of a Federal program. A subaward may be provided through any form of legal agreement, including an agreement that the pass-through entity considers a contract. The term includes consortium agreements.
A subproject is a discrete and clearly identifiable segment of a multicomponent application which has an identified project leader (may be different from the principal investigator on the application) and a separate budget. A subproject may include a scientific investigation, the provision of a service or resource, or a combination of activities and receives a specific review assignment and assessment (score and/or descriptor). Most commonly, subprojects are part of the M,P,S, and U mechanisms. A consortium/subcontract is not the same as a subproject.
A non-Federal entity that receives a subaward from a pass-through entity to carry out part of a Federal program; but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency. The term includes consortium participants.
Indicates the percentage of reviewed RPG applications receiving funding computed on a fiscal year basis. It is determined by dividing the number of competing applications funded by the sum of the total number of competing applications reviewed and the number of funded carryovers.
NOTE: Applications having one or more amendments in the same fiscal year are only counted once. Success rate computations exclude SBIR/STTRs.
For additional information see post on paylines, percentiles and success rates.
Success Rate Base
The basis for computing the Research Project Grant (RPG) success rate. It includes the total number of competing applications reviewed (the number of applications subjected to a streamlined review process).
Also known as Rate Base.
Process whereby the rights to and obligations under an NIH grant(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s). A SII may result from legislative or other legal action, such as a merger or other corporate change.
A combination of the reviewers' written comments and the SRO's summary of the members' discussion during the study section meeting. It includes the recommendations of the study section, a recommended budget, and administrative notes of special considerations.
A request for additional funds either for the current operating year or for any future year recommended previously.
Also known as a Type 3 application or award, a supplement can be either non-competing (administrative) or competing (subject to peer review); however, the latter is now called 'Revision'.
All tangible personal property other than those described in Equipment. A computing device is a supply if the acquisition cost is less than the lesser of the capitalization level established by the non-Federal entity for financial statement purposes or $5,000, regardless of the length of its useful life. See Computing devices and Equipment.
Provides centralized support activities for grants management, program and peer review activities. Before the advent of DEAS, these activities were carried out by extramural staff located at individual Institutes and Centers.
Suspension of Award Activities
An action by the NIH awarding IC requiring the recipient to cease all activities on the award pending corrective action by the recipient. It is a separate action from suspension under HHS regulations (2 CFR 376) implementing Executive Orders 12549 and 12689. (See Public Policy Requirements and Objectives-Debarment and Suspension and Administrative Requirements-Enforcement Actions).
System for Award Management (SAM)
As of July 2012, the System for Award Management (SAM) replaced the Central Contractor Registry (CCR).The System for Award Management (SAM) is a website that consolidates Federal procurement systems and the Catalog of Federal Domestic Assistance (CFDA). Currently CCR, FedReg, ORCA and EPLS have been migrated to SAM. You must be registered on SAM (within the Entity Management section), Grants.gov and eRA Commons to successfully submit an application to NIH.
Most system issues are technical problems with federal systems used for electronic submission of grant applications (e.g., ASSIST, Grants.gov, eRA Commons, SAM) that keep an applicant from successfully submitting their grant application on time. System issues must be reported to the eRA Service Desk on or before the deadline and will be investigated on a case-by-case basis. Please note: Problems with computer systems at the applicant organization, failure to complete required registrations by the submission deadline or failure to follow documented instructions are not typically considered system issues.
Learn more about our Guidelines for Applicants Experiencing System Issues.
Research funded as a result of an I nstitute set aside of dollars for a specific scientific area. Institutes solicit applications using research initiatives (RFAs for grants, RFPs for contracts). Targeted research applications are reviewed by chartered peer review committees within I nstitutes. The opposite is Investigator-Initiated Research.
Targeted/Planned Enrollment Data
Provides race and ethnicity data for projected number of human subject participants to be enrolled in an NIH-funded clinical research study. The data is provided in competing applications and annual progress reports.
Total Direct Cost
Sharing of knowledge and facilities among F ederal laboratories, industry, universities, G overnment, and others to make federally generated scientific and technological advances accessible to private industry and S tate and local G overnments. Go to NIH Office of Technology Transfer.
The ending of a Federal award, in whole or in part at any time prior to the planned end of period of performance.
Terms and Conditions of Award
All legal requirements imposed on a grant by NIH, whether based on statue, regulation, policy, or other document referenced in the grant award, or specified by the grant award document itself. The Notice of Award may include both standard and special conditions that are considered necessary to attain the grant's objectives, facilitate post award administration of the grant, conserve grant funds, or otherwise protect the Federal Government's interests.
When applications are submitted collaboratively the applications are associated and reviewed as a single project. If selected for funding, each application will receive a separate award to fund the collaborative project. The awards may be linked together through special terms and conditions. Note this term may also apply when a single consolidated application is submitted involving multiple components that ultimately receive separate, but linked awards.
Third-Party in-Kind Contributions
The value of non-cash contributions (i.e., property or services) that: (1) Benefit a federally assisted project or program; and (2) Are contributed by non-Federal third parties, without charge, to a non- Federal entity under a Federal award.
Federal Taxpayer Identification Number (same as EIN)
The total allowable costs (both direct costs and F&A costs) incurred by the recipient to carry out a grant-supported project or activity. Total project costs include costs charged to the NIH grant and costs borne by the recipient to satisfy a matching or cost-sharing requirement.
Awards designed to support the research training of scientists for careers in the biomedical and behavioral sciences, as well as help professional schools to establish, expand, or improve programs of continuing professional education. Training awards consist of institutional training grants (T) and individual fellowships (F). Go to NIH Research Training Opportunities.
Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.
Transparency Act (Federal Funding Accountability and Transparency Act)
The Federal Funding Accountability and Transparency Act of 2006, as amended ("Transparency Act"), requires the Office of Management and Budget to establish a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards. See Federal Funding Accountability and Transparency Act.
Group underrepresented in the biomedical, clinical, behavioral, and social sciences, such as people with disabilities, people from disadvantaged backgrounds, and underrepresented racial and ethnic groups such as blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians and other Pacific Islanders.
Used as an eligibility requirement for diversity supplements, fellowships (F31), and other NIH programs. Also see and minority group.
In an effort to streamline the Federal government's guidance on administrative requirements, cost principles, and audit requirements for Federal awards, the Office of Management and Budget has issued final guidance (referred to as ‘Uniform Guidance’) that supersedes A-21, A-87, A-110, A-122, A-89, A-102, A-133, and the guidance in circular A-50 on Single Audit Act follow-up. By consolidating these 8 circulars, the uniform guidance provides a streamlined format that improves both clarity and accessibility. It is located in Title 2 of the Code of Federal Regulations (CFR), Part 200. For more information, see https://cfo.gov/cofar/ for related links to 2 CFR 200, other guidance documents, and recently updated Frequently Asked Question. Note, for NIH grantees The Department of Health and Human Services is considered the implementing agency and will issue implementation guidance once approved by OMB.
The 50 States, territories, and possessions of the United States, the Commonwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the District of Columbia.
For 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.
The amount of funds authorized under a Federal award that the non-Federal entity has not obligated. The amount is computed by subtracting the cumulative amount of the non-Federal entity's unliquidated obligations and expenditures of funds under the Federal award from the cumulative amount of the funds that the Federal awarding agency or pass-through entity authorized the non-Federal entity to obligate.
USA Patriot Act
The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) (P.L. 107-56) amends 18 U.S.C. 10 and provides criminal penalties for possession of any biological agent, toxin, or delivery system of a type or in a quantity that is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The Act also establishes restrictions on access to specified materials. "Restricted persons," as defined by the Act, may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select agent.
This term means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are: allocation of study participants of both sexes/genders (males and females) and from different racial and/or ethnic groups to the intervention and control groups by an unbiased process such as randomization; unbiased evaluation of the outcome(s) of study participants; and use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects by sex/gender, race, and/or ethnicity.
The system check made by NIH's electronic systems of grant applications against the NIH application guide and Funding Opportunity Announcement instructions. The process can generate errors or warnings.
Venture Capital Operating Company
For purposes of the SBIR/STTR programs, venture capital operating company means an entity described in § 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
Warnings are notices that alert an applicant to pay particular attention to specific instructions in the funding opportunity announcement or the application guide. The applicant may choose whether or not they wish to correct the issue that prompted the warning; the application will move forward in the submission process even if the warning is not corrected. If the application does not comply with the instructions, the applicant may be notified of the problem later in the review process and the application may not be considered for review.
An application that has been removed for consideration of award by the Signing Official/Authorized Organization Representative.
Withholding of Support
A decision by NIH not to make a non-competing continuation award within the current competitive segment.
Extramural Trainee Reporting and Career Tracking System
System for Administration of Appointments and Terminations for Institutional and Individual Training Awards
xTrain provides program directors/principal investigators, university administrators, and trainees the ability to electronically prepare and submit PHS 2271 Statement of Appointment forms and PHS 416-7 Termination Notices associated with institutional research training grants, institutional career development awards, individual fellowships and research education awards.