Account Administrator (AA)
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
- May be the same person as the signing official.
- Resides in either the central research administration office or academic departments.
- Create additional AO and PI accounts
- Not authorized to transmit applications to the NIH.
Alien Registration - Card
Animals in Research
Application Viewing Window
Within the viewing window, an 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.
Assistant Role (ASST)
Authorized Organization Representative (AOR)
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.
Cluster of Programs
Contract Transaction Types
|Type 1||New contract|
|Type 4||Letter contract|
|Type 5||Continuation of an incrementally (typically, in one year increments) funded contract|
|Type 6||Task orders and subsequent modifications relating to existing ordering agreements|
|Type 7||Exercise of option|
Cooperative Research and Development Agreement
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.
Covered Small Business Concern
- Was not majority-owned by multiple venture capital operating companies (VCOCs), hedge funds, or private equity firms on the date on which it submitted an application in response to a solicitation under the SBIR program; and
- Is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms on the date of the SBIR award.
Cumulative Inclusion Enrollment Report
Data and Safety Monitoring Plan
Departmental Grants Appeals Board
Dual Review System
Electronic Streamlined Non-Competing Award Process (eSNAP)
In context of awarded grant:
The date signifying the end of the current project period, after which the grantee is not authorized to obligate grant funds.
In context of funding opportunity announcement key dates:
The day after the last submission due date for the announcement. As of the Expiration Date, the announcement is no longer active and applications will not be accepted unless either the late policy or system issue policy apply.