Extramural Glossary

This funding mechanism is designed to enhance the research environment of educational institutions that have not been traditional recipients of NIH research funds (i.e., health professional academic institutions with less than $3 million of NIH support in total costs in four or more of the last seven years), this award provides limited funds to those institutions? faculty members to develop new research projects or expand ongoing research activities in health sciences and to encourage students to participate in the research activity. The NIH invites applications for R15 AREA grants through a standing, ongoing Program Announcement. These grants support small-scale research projects conducted by faculty in primarily baccalaureate degree-granting domestic institutions. Awards are for up to $75,000 for direct costs (plus applicable indirect costs) for periods not to exceed 36 months. For details see: http://grants.nih.gov/grants/funding/area.htm

The process that may be used by the NCI Scientific Program Leadership (SPL) to consider and fund applications whose priority scores are just beyond the payline.

For some grant mechanisms (e.g., P01 applications) this process is used to allow applicants whose applications are close to, but not within, the payline to submit a brief response (within a set page limit and by a set date) to the summary statement (i.e., the reviewers' comments) without having to submit an amended application at the next submission deadline.

A proposal judged to be complete in itself, to contain no major deficiencies, and to present sufficient evidence to indicate that the offeror is capable of satisfying the minimum requirements of the Request for Proposal (RFP) and is thus eligible for further consideration.

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 NIH eRA Commons (https://commons.era.nih.gov/), a personal account an individual uses to log into the NIH eRA Commons which is identified by a unique combination of username and password.

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.

An accounting method whereby revenues and expenses are identified with specific periods of time, such as a month or year, and are recorded when they are earned or incurred without regard to the date of receipt or payment of cash; distinguished from cash basis.

Numbers of human subjects/patients recruited/enrolled into a research study (e.g., a clinical trial).

The charges incurred by the recipient during a given period requiring the provision of funds for:

1. goods and other tangible property received;
2. services performed by employees, contractors, subrecipients, subcontractors, and other payees; and
3. other amounts becoming owed under programs for which no current service or performance is required, such as annuities, insurance claims, and other benefit payments.

The sum of:

1. earnings during a given period from services performed by the recipient and from goods and other tangible property delivered to purchasers; and
2. amounts becoming owed to the recipient for which no current service or performance is required by the recipient.

A disease in which there is a severe loss of the body's cellular immunity, greatly lowering the resistance to infection and malignancy.

Contract award; the decision by the authorized contracting officer to officially award a contract to an offeror.

The net invoice price of property or supplies including the cost of modifications, attachments, accessories, or auxiliary apparatus necessary to make the property usable for the purpose for which it was acquired.

A document used to initiate an acquisition action which provides the background information necessary for the preparation of the Request for Proposal. (See Section IV, D, of the Research Contracts Branch's Orange Book).

The acquiring by contract with appropriated funds of supplies or services by and for the direct benefit or use of the Federal Government.

Requires justification.

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

This is an initiative created by the Division of Cancer Biology that provides limited supplemental support to current DCB-funded investigators for meetings/workshops or grant-related research activities to establish focused scientific research collaboration in novel and promising areas related to the parent grant.

Activity codes are three-digit alphanumeric combinations that identify a specific category of extramural activity or mechanism of support. The NIH has more than 100 research support mechanisms. For a comprehensive list of activity codes, see: http://grants.nih.gov/grants/funding/ac_search_results.htm.

Review of application(s) or contract(s) by experts selected on a temporary basis for their expertise and experience.

The ACF, within the Department of Health and Human Services, is responsible for federal programs that promote the economic and social well-being of families, children, individuals, and communities.

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.

Additional comments/concerns that may be included in Summary Statements (SS).

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.

The areas the ARC assist with are budget, travel, procurement and space management. The ARC manager reports to the Deputy Associate Director, Office of Management , NCI. The ARC mission statement says that the ARC is to be a recognized leader in the field of administration, providing the highest quality customer service available to our NCI programs whose ultimate goal is to find a cure for cancer. To this end, we strive to provide expert, confidential, and efficient administrative service with professionalism, integrity and compassion.

Funds added to a grant without peer review to pay for items within the scope of an award but unforeseen when a grant application was submitted

A payment made by Treasury check or other appropriate payment mechanism to a recipient upon its request either before cash disbursements are made by the recipient or through the use of predetermined payment schedules.

Agreement negotiated before a contractor incurs a cost, specifying whether a cost is allowable. An advance agreement may be negotiated before or during a contract and must be in writing. Advance agreements may be specific to a contract, group of contracts, or all contracts of a contracting office, agency, or several agencies.

In most cases, the Referral Officer will deliver these copies of applications provided by applicant(s) to the appropriate Scientific Review Administrator and Program Director.

Unanticipated problem or unfavorable symptom or disease occurring during a clinical study, though not necessarily caused by the study treatment, which harms subjects or others, for example, a loss of research records, drug overdose, serious symptom, or death. Go to 45 CFR part 46, subpart A.

Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medical treatment or procedure regardless of whether it is considered related to the medical treatment or procedure.

An electronic system for expedited submission of adverse event reports that is used by the NCI Clinical Trials Evaluation Program.

Adverse event collection and reporting is a routine part of every clinical trial. The first step is to identify the event using the Common Toxicity Criteria (CTC). The severity of the event should then be graded using the CTC criteria. Next, determine if the adverse event is related to the medical treatment or procedure (attribution). If so, determine whether the adverse event is expected or unexpected. With this information and the adverse event reporting section in each protocol, the investigator can determine whether an adverse event should be reported to the NCI as an expedited report (AdEERS) or a routine report (CDUS or CTMS).

Provides advice and recommendations for the oversight of specific programs to the Director of an NIH Institute or Center; there is an ACD in the NCI.

Chartered Institute advisory committee that performs the second level of peer review, makes funding and policy recommendations, and helps develop research initiatives. In the NCI, this council is called the National Cancer Advisory Board.

This term has the same meaning as set forth in 13 CFR Part 121 - Small Business Size Regulations, §121.103, 'What is affiliation?'

Who or what someone or something is associated with (e.g., a person's institutional affiliation would be the institution(s) he/she is associated with).

This agency in the U.S. Dept. of Health and Human Services provides evidence-based information on health care outcomes; quality; and cost, use, and access. Information from AHRQ’’s research helps people make more informed decisions and improve the quality of health care services. AHRQ was formerly known as the Agency for Health Care Policy and Research.

Effective FY 1993, the service components of the ADAMHA became the Substance Abuse and Mental Health Services Administration (SAMHSA). The three research components of the ADAMHA - the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH) - became part of the NIH.

The DHHS Alert System is now located in the Office of Research Integrity (ORI), Office of Public Health and Science (OPHS), Office of the Secretary(OS). The system allows the NIH to identify research contract proposals that include a principal investigator who is under formal investigation. See Manuual Chapter 6309-1 at http://www1.od.nih.gov/oma/manualchapters/contracts/6309-1/

Commonly known as "Green Card," shows a person's status as a permanent resident with a right to live and work permanently in the U.S. Also called Form I-551.

Those costs that are reasonable, allocable, consistently applied and not specifically prohibited by federal regulation. Cost that is reasonable, meets accepted accounting principles, is defined in the Federal Acquisition Regulation (FAR) 31, or is agreed to by the contracting parties.

Used in activity codes to identify specific categories of extramural activity or mechanisms of support and also used in application identification numbers.

Grant budget category referring to work to change the interior or other physical characteristics of an existing facility or installed equipment.

An application that has been revised and resubmitted after one or two submissions and reviews (an A1 and an A2 application, respectively).

Resubmission of an unfunded application that has been revised in response to a prior NIH peer review.

A person having origins in the original peoples of North, Central, or South America who maintains tribal affiliation or community.

The American Recovery and Reinvestment Act of 2009 was signed into law by President Obama on February 17th, 2009. The Act includes measures to modernize our nation's infrastructure, enhance energy independence, expand educational opportunities, preserve and improve affordable health care, provide tax relief, and protect those in greatest need.

Human subjects term indicating NIH requirements for analysis plans which depend on the type of research proposed. They may include monitoring to detect and address adverse effects of the research as well as the ability to detect intervention differences among different types of human subjects, for example women and minorities, ethnic or racial subgroups, and children. Requirements also differ depending on the risk and complexity of the study and the probability of finding differences in the intervention effect for participant subgroups. For grantees, renewal applications (as well as contract proposals) must include the results of such subgroup analyses.

Refers to special requirements that apply to NIH grants or contracts involving the use of live vertebrate animals in research, training, experimentation, testing, and related purposes.

Federal statutes and regulations pertaining to animals.

Document that 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.

Any live, vertebrate animal used for research, research training, biological testing, or related purposes. Go to the PHS Policy on Humane Care and Use of Laboratory Animals web site for information and links to legislation

Number that a scientific review group places on a summary statement during initial peer review reflecting the application of regulations for research animals to a project; some codes indicate a concern that would result in a bar to award.

Based on a grant's start date, date used as the basis for funding noncompeting and competing continuation awards. NCI cannot fund these awards before the anniversary date.

A procedure for contesting the peer review of a grant application. Synonymous with "rebuttal."

Procedure for contesting an initial peer review of a grant application. Synonymous with "Rebuttal."

Designated IC Offical responsible for providing guidance to staff to help resolve issues related to appeal of review. At NCI, the DEA Director serves as the Appeal Officer as well as the Executive Secretary of the NCAB. In that capacity, he/she ensures that Board members receive all necessary documentation and that the Board considers all appeals as per NIH policy.

An Appendix or Appendices to a grant application may include reprints, manuscripts, figures, photographs, etc. These items may be submitted with any type of application and are usually received in limited numbers.

The organizational entity that, at the time of award, will qualify as a Small Business Concern (SBC) and that submits a grant application for a funding agreement under the SBIR or STTR Program.

A formal request for National Institutes of Health funds

The application number identifies: 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 resubmission [previously "amendment"] (A1), supplement (S1), or a fellowship's institutional allowance. For contracts, the suffix is replaced by a modification number. Sample Application Identification Number: 1-R01-CA164529-01A1S1

Three unique numbers identify each application: an application identification number, an accession number, and a five-part assignment number. The parts of the assignment number include:
Application TypeIActivity CodeIAwarding Unit/ ICISerialNo.ISuffixes
1 R01 CA 12789 Yr/Other
01/A1

Also called a Reverse Site Visit. This method of review of a grant application is conducted only for amended multicomponent (e.g., Program Project) applications when they have been changed substantially by the applicant in response to comments stated in the summary statement document after review of the previous application.

Broad category of grant application, noted as the first digit on an application identification number. Type 1: New Application, Type 2: Competing continuation (renewal) application. Type 3: Supplement to current grant application. Type 4: Extension (noncompetitive) application. Type 5: Noncompeting continuation application. Type 6: Change of institute or center (new training programs) (Not used since the 1970's) application. Type 7: Change of grantee or training institution application. Type 8: Change of institute or center (noncompeting continuation) application. Type 9: Change of institute or center (competing continuation) application.

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. Unlike the error correction window which begins the day after the submission deadline, the application viewing window is linked to the time of submission (i.e., begins the day after the assembled application image is posted in Commons). 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.

Satisfies the information requirements of the Division and coordinates IRM activities with other relevant NCI and NIH units and provides high quality information analysis, design, development, and coordination of applications in support of Divisional business processes. Also serves as the focal point for the Division in the development, deployment and application of specialized software and data bases required for the conduct of review, referral, coding, advisory, and other extramural applications.

The adequacy and quality of the experimental approaches, as well as the overall design, presented in a grant application. Also called "budget appropriation."

The statute that provides the authority for Federal agencies to incur obligations and to make payments out of the U.S. Treasury for specified purposes.

A legislative act authorizing the expenditure of a designated amount of public funds for a specific purpose.

A list sent by the program office to the Grants Management Officer, showing which grant applications on the list are approved for funding and in what order.

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.

A person having origins in the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.

Agreement to participate in research by someone who is not competent to give informaed consent, e.g., a child.

At the first level of assignment, applications are assigned by Referral Officers in the Center of Scientific Review (CSR) to specific Institutes/Centers (ICs) of the NIH for funding and to CSR or specific ICs for review. At the second level of assignment, applications are assigned to NIH (CSR or NCI) Scientific Review Administrators (SRAs) and NIH (NCI) Program Directors who are responsible for managing the peer review and award processes, respectively. At the third level of review, the SRAs are responsible for assignment of applications to particular peer reviewers.

Extent to which an individual enters a new culture and becomes a part of it. Includes both the motivation of the individual to enter the mainstream culture and the extent to which members of the mainstream culture welcome or discourage the entry and inclusion of that person in the mainstream culture.

The award of money, property, services, or anything of value to a recipient to accomplish a public purpose of stimulation or support authorized by a Federal statute. Assistance mechanisms such as grants and cooperative agreements are awarded in less detail than are acquisitions, such as contracts, and responsibilities for ensuring performance rest largely with a recipient or may be shared with the government.

A grant or cooperative agreement.

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.

AAALAC is a private nonprofit organization that promotes the humane treatment of animals in science through a voluntary accreditation program. More than 640 companies, universities, hospitals, government agencies and other research institutions have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC's program, in addition to complying with the local, state and federal laws that regulate animal research.

A certification by an applicant, normally included with the application or State plan, that it will abide by a particular requirement if awarded a Federal grant.

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.

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.

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.

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. Also called "Institutional business official."

The designated representative of the grantee organization in matters related to the award and administration of its NIH grants. In signing a grant application, this individual certifies that the applicant organization will comply with all applicable assurances and certifications referenced in the application. This individual's signature on the grant application further certifies that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application.

End-of-fiscal-year budget items that can be paid when extra money is available.

The dollar amount a grant award is reduced from the amount recommended by the scientific review group in initial peer review. This is done so institutes can maintain a sufficient number of grants in their portfolio and combat inflation of grant costs.

An official letter that is submitted electronically over a secure web site by a Program Director to signify that his/her institute or center (IC) agrees to accept the submission of a grant application (typically involving a request for greater than or equal to $500,000 per year in direct costs) for peer review and possible funding. An ARA letter can also be used by a Program Director to inform the responsible Scientific Review Group or Administrator that an application will be submitted late (i.e., after the official deadline).

The provision of funds based on an approved application and budget to provide general financial assistance to an organization or an individual to carry out an activity or program.

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.

Also called a Grantee. The person or persons who have submitted a grant application to the NIH and, following peer review and the decision making process, have been awarded funds by an NIH Institute or Center to conduct a specific program of research.

Any department, agency, commission, or instrumentality in the executive branch of the Federal Government that makes awards to eligible recipients.

The NIH Institute or Center responsible for the award, administration, and monitoring of grant-supported activities.