See Alteration and Renovation

A grant meeting the following criteria:

1. Today's date is between the budget start and end dates.
2. The grant has an eRA System (IMPAC II) application status code of "Awarded. Non-fellowships only." or "Awarded. Fellowships only."

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.

• 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.

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.

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

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).

See Resubmission.

See Authorized Organization Representative

See Annual Payback Activities Certification

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.

• type of application (1)
• activity code (R01)
• organization to which it is assigned (AI)
• serial number assigned by the Center for Scientific Review (CSR) (183723),
• suffix showing the support year for the grant (-01)
• other information identifying a revision (S1), resubmission (A1), or a fellowship's institutional allowance. For contracts, the suffix is replaced by a modification number.

The Application Submission System & Interface for Submission Tracking (ASSIST) is a web-based system used to prepare multi-project (also known as multi-component or complex) grant applications using the SF424 Research & Related form set and to submit electronically through Grants.gov to NIH and other participating agencies. See ASSIST FAQs.

A single-digit code identifying the type of application received and processed. Application type codes include the following:

1=New

2=Renewal

3=Revision

4=Extension

5=Non-Competing Continuation

6=Change of Organization Status (Successor-In-Interest)

7=Change of Recipient or Training Institution

8=Change of Institute or Division (Type 5 transfer to another NIH IC)

See Application Submission System & Interface for Submission Tracking (ASSIST)

See Assistant Role

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.

See Best and Final Offer

See Biomedical Research and Development Price Index

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.

See Central Contractor Registration Database.

See Career Development Awards

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.

As of July 2012, Central Contractor Registry (CCR) has been replaced with the System for Awards Management (SAM).

See Catalog of Federal Domestic Assistance

See Code of Federal Regulations

The NIH Policy on Inclusion of Children defines a child as an individual under the age of 18 years. The intent of the NIH policy is to provide the opportunity for children to participate in research studies when there is a sound scientific rationale for including them, and their participation benefits children and is appropriate under existing Federal guidelines. Thus, children must be included in NIH conducted or supported clinical research unless there are scientific or ethical reasons not to include them.

DHHS Regulations (45 CFR part 46, Subpart D, Sec.401-409) provide additional protections for children involved as subjects in research, based on this definition: "Children are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted." Generally, state laws define what constitutes a “child.” Consequently, the age at which a child's own consent is required and sufficient to participate in research will vary according to state law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.

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. 

The Close Date of a funding opportunity announcement is the date the funding agency lists in Grants.gov as the last submission due date for the announcement.

See Committee Management Officer

• identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol or combination thereof (i.e., the code); and
• a key to decipher the code exists, enabling linkage of the identifying information with the private information or specimens.

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:

• the specimens and/or information/data are not obtained from an interaction/intervention with the subject specifically for the research; and
• the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain (e.g., the researcher's access to subject identities is prohibited).

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 the following guidance from the Office for Human Research Protections (OHRP) for additional information and examples: http://www.hhs.gov/ohrp/policy/cdebiol.html.)

See Council on Financial Assistance Reform

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.

A 'component type' is a named, agency-defined collection of forms that may be repeated within a multi-project grant application.

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.

An entity that receives a contract. See contract.

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/.

1. 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
    
2. Is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms on the date of the SBIR award.

See Consumer Price Index

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

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.

See Expanded Authorities

See Electronic Research Administration

See Early Stage Investigator

See Electronic Streamlined Non-Competing award Process

(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:
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.

See Federal Advisory Committee Act

See Federal Acquisition Regulations

See Federal Demonstration Partnership

Laws regulating government contracting. Go to FAR.

Depending on the context, in either paragraph (1) or (2) of this section:
(1)(i) The Federal financial assistance that a non-Federal entity receives directly from a Federal awarding agency or indirectly from a pass-through entity, as described in 45 CFR 75.101; or

(ii) The cost-reimbursement contract under the Federal Acquisition Regulations that a non-Federal entity receives directly from a Federal awarding agency or indirectly from a pass-through entity, as described in 45 CFR 75.101.

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

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

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

(i) Grants;

(ii) Cooperative agreements;

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

(iv) Direct appropriations;

(v) Food commodities; and

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

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

(i) Loans;

(ii) Loan Guarantees;

(iii) Interest subsidies; and

(iv) Insurance.

(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. 

See Federal Financial Report

See Funding Opportunity Announcement

See Freedom of Information Act

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:

• collaborations with investigators at a foreign site anticipated to result in co-authorship;

• use of facilities or instrumentation at a foreign site; or

• receipt of financial support or resources from a foreign entity.

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

A 'form' is a named collection of data fields approved by the Office of Management and Budget (OMB).

See Final Proposal Revision

See Financial Status Report

See Federal Technology Transfer Act

See Federal-Wide Assurance

See Fiscal Year

See Grants Management Officer

See Grants Management Specialist

See Government Printing Office

• type of application (1)
• activity code (R01)
• organization to which it is assigned (AI)
• serial number assigned by the Center for Scientific Review (183723),
• suffix showing the support year for the grant (-01)
• other information identifying a revision (S1), resubmission (A1), or a fellowship's institutional allowance. For contracts, the suffix is replaced by a modification number.

Sample Grant Number 1 R01 AI 183723 -01 A1 S1

A legal instrument of financial assistance between a Federal awarding agency or pass-through entity and a non-Federal entity that, consistent with 31 U.S.C. 6302, 6304:
(1) Is used to enter into a relationship the principal purpose of which is to transfer anything of value from the Federal awarding agency or 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 awarding agency or pass-through entity's direct benefit or use;
(2) Is distinguished from a cooperative agreement in that it does not provide for substantial involvement between the Federal awarding agency or pass-through entity and the non-Federal entity in carrying out the activity contemplated by the Federal award.
(3) Does not include an agreement that provides only:

(i) Direct United States Government cash assistance to an individual;
(ii) A subsidy;
(iii) A loan;
(iv) A loan guarantee; or
(v) Insurance.

A small business concern meeting the following criteria:
1. Located in a “historically underutilized business zone” or HUBZone area located in one or more of the following:

• A qualified census tract (as defined in section 42(d)(5)(C)(i)(l) of the Internal Revenue Code of 1986; or
• A qualified “non-metropolitan county” (as defined in section 143(k)(2)(B) of the Internal Revenue Code of 1986) with a median household income of less than 80 percent of the state median household income or with an unemployment rate of not less than 140 percent of the statewide average, based on U.S. Department of Labor recent data; or
• Lands within the boundaries of Federally recognized Indian reservations.

2. Owned and controlled by one or more U.S. Citizens.
3. At least 35% of its employees must reside in a HUBZone.

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

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

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).

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.

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.

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. 

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.

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

See Integrated Review Group (IRG)

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.

See Career Development Awards

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.

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.

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.

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 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 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.

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

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 National Institute of Environmental Health Sciences

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.

See NIH Grants Policy Statement (NIHGPS)

NIH National Institute of Nursing Research

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.

See Notice

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

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

The Executive Office of the President, Office of Management and Budget.

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

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

 Some (but not all) of these OMB Circulars 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.

NOTE

• For both paper and electronic submissions, when these dates fall on a weekend or holiday, they are extended to the next business day.
• Requests for Applications (RFAs) and Program Announcements with Special Referral Considerations (PARs) with special receipt dates always must be received (by Grants.gov for electronic applications and the Center for Scientific Review for paper applications) on the dates designated in the announcement to be on time.

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.

Grant Number
3 R01 CA 12921(9) -04 S1A1

In the example above, "CA" refers to the National Cancer Institute. For certain activities, DHHS organizations having Bureau status may use a Division-level code. An interagency agreement awarded by NCI, for instance, may be coded 1Y01CM00999-00, where CM refers to NCI's Division of Cancer Treatment.

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.

'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. 

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.

 See Program Announcement (PA).

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

Learn more about types of funding opportunity announcements .

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.

See Program Announcement with Set-Aside Funds.

A non-Federal entity that provides a subaward to a subrecipient to carry out part of a Federal program.

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.

See Program Director/Principal Investigator

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

The 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.

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.

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.

An application requiring competitive peer review and Institute/Center action to continue beyond the SBIR/STTR Phase II award.

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.

See e-Business Point of Contact

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).

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 Announcement with special receipt, referral and/or review considerations. 

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).

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.

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

Real property or personal property.

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.

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).

A web-based tool that institutions can use to track compliance of publications that fall under the NIH Public Access Policy.

• R01 equivalents include substantial NIH research grants like the R01 that are, or have historically been used as funding vehicles to launch an independent research career.
   
• The collection of awards considered R01 equivalents changes over time reflecting changes in the types of grants being offered by the NIH. 
   
• In FY2017, the term “R01-equivalents” refers to these current and historical activity codes: R01, R35-MIRA*, R37, RF1, R23**, R29**, DP1, DP2, DP5, U01, RL1.

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."

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.

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.

• Fabrication is making up data or results and recording or reporting them.
• Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record.
• Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
• Research misconduct does not include honest error or honest differences of opinion.

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

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:

• R00, R01, R03, R15, R21, R33, R34, R35, R36, R37, R50, R56, R61, RC1, RC2, RC3, RC4, RF1, RL1, RL2, RL9, P01, P42, PM1, PN1, RM1, UA5, UC1, UC2, UC3, UC4, UC7, UF1, UG3, UH2, UH3, UH5, UM1, UM2, U01, U19, U34, DP1, DP2, DP3, DP4, DP5.

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.

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.

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.

See Request for Application.

See Request for Proposals.

• In the eRA Commons system a person with the Signing Official (SO) role can electronically sign and submit applications, progress reports and other official grant documents to the agency on behalf of their organization.
• In the Grants.gov system a person with the Authorized Organization Representative (AOR) role can submit grant applications for their organization.

See Research Project Grant

See System for Award Management (SAM)

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)

A peer review committee group of primarily non-government experts (peer reviewers), qualified by training or experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the applications under review, to evaluate and give expert advice on the scientific and technical merit of the applications. No more than one-fourth of the members of any SRG may be Federal employees, as noted in 42 CFR 52(h).

The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h).

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

The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. 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.

See Special Emphasis Panel

See Standard Form 424 (Research & Related) (SF424 (R&R))

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).

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.

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.

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.

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.

See Scientific Review Group

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.

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.

Routinely applied to:

all 'K' awards and 'R; awards, except R35s. Awards excluded from SNAP are those that do not having the authority to automatically carry over un-obligated balances (centers, cooperative agreements, Kirschstein-NRSA institutional training grants, non-Fast Track Phase I SBIR and STTR awards, clinical trials (regardless of activity code),

Program Project Grants (P01s), R35s and awards to individuals. See section 8.4.1.2 Streamlined Non-Competing Award Process in the NIHGPS for additional information.

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.

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.

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.

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).

As of July 2012, the System for Award Management (SAM) replaced the Central Contractor Registry (CCR).

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.

The ending of a Federal award, in whole or in part at any time prior to the planned end of period of performance. 

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.

See Cooperative Agreement

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.

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.

See Application Viewing Window.

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