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NIAID Glossary of Funding and Policy Terms and Acronyms

For Institute program-specific acronyms, go to NIAID Profile and Fact Book.

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2590 See PHS 2590.
398 See PHS 398.
416-1 See PHS 416-1.
424 See SF 424.

45 CFR Part 46

Code of Federal Regulations covering protection of human subjects. 45 CFR 46 is divided into four subparts: A, B, C, and D. Subpart A, known as the Common Rule, governs human subjects research for virtually all relevant federal agencies; Subparts B, C, and D address special areas.

Public Health Service Act, 42 USC 201, and Health Research Extension Act of 1985, Public Law 99-158, are the laws underlying 45 CFR 46. Go to definitions 45 CFR 46.102, full 45 CFR 46, and NIAID's Human Subjects, Clinical Research.

AAALAC Association for Assessment and Accreditation of Laboratory Animal Care. Go to AAALAC.

For electronic applications, see Project Summary/Abstract and Project Narrative. For paper PHS 398 grant applications, see Description. Go to NIAID's Project Summary/Abstract and Project Narrative in the NIH Grant Cycle: Application to Renewal.

Academic research enhancement award (AREA)

Grant award that stimulates research at health professional academic institutions with less than $3 million of NIH support in total costs in four or more of the last seven years.

Go to NIH AREA and NIAID's Academic Research Enhancement Awards SOP.

Accelerated development/review

Process that speeds the development of new drugs that promise significant benefit over existing therapy for serious illnesses. This includes illnesses for which no therapy exists. This process makes sure the rapid development is balanced by safeguards to protect patients.

See Accelerated Development/Review in FDA's Handbook for more information.

Acceptable proposal

Contract proposal judged by the majority of a technical evaluation group to be eligible for inclusion in a competitive range or award. Go to NIAID's R&D Contracts.
Accounting Act, Budget See Budget and Accounting Act.
Acquisition Obtaining of supplies or services by the federal government with appropriated funds through purchase or lease. Go to NIAID's R&D Contracts.
Acquisition plan Document a contracting officer uses to begin preparing a request for proposals following concept clearance for a new acquisition or major change in an existing project. Go to NIAID's Acquisition Planning Resources on R&D Contracts.
Activity code

Three digit identifier of an award type, e.g., R01 is a research project grant. For budget purposes, activity codes are grouped into funding mechanisms, and the terms are often used interchangeably. Major series of activity codes are:

For descriptions, go to NIAID's Grants portals, Selection of Appropriate Funding Mechanisms SOP, and Award Types questions and answers.

Administrative change

Unilateral, written change that does not affect rights of the contracting parties. Go to NIAID's R&D Contracts.
Administrative standards See OMB circulars.
Administrative supplement Monies 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. Go to NIAID's Administrative Supplements to Grants and Cooperative Agreements SOP.

Adult stem cell

Stem cell from a developed organism, including multipotent, oligopotent, and unipotent but not pluripotent or totipotent stem cells.
Advance agreement

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

Go to NIAID's R&D Contracts.

Adverse device effect

Serious adverse effect on health and safety of human subjects from a device. See also unanticipated adverse device effect. Go to Human Subjects, Clinical Research.
Adverse effect

Unanticipated problem or unfavorable symptom or disease occurring during a clinical study. Though not necessarily caused by the study treatment, it can harm subjects or others, for example, a loss of research records, drug overdose, serious symptom, or death.

Go to 45 CFR part 46, subpart A and NIAID's Human Subjects, Clinical Research.

Adverse event

Occurrence of an adverse effect occurring during a clinical study. Also see serious adverse event. Go to 45 CFR part 46, subpart A and NIAID's Human Subjects, Clinical Research.

Advisory council See Council, advisory and National Advisory Allergy and Infectious Diseases Council.
AERIO See Agency Extramural Research Integrity Officer.
Agency Extramural Research Integrity Officer NIH extramural program officer who evaluates the merit of research misconduct allegations and reports research misconduct findings to appropriate staff. Also see RIO.

HHS AIDS information site. Go to AIDSinfo.

AIDS-related research

Studies of the etiology, epidemiology, natural history, diagnosis, treatment, or prevention of AIDS and its sequelae. Does not include all research of T lymphocytes or retroviruses. For more information, call a program officer in NIAID's Division of AIDS.

AIDS Research Advisory Committee Chartered committee that makes recommendations about all aspects of HIV and AIDS research relating to the mission of the NIAID Division of AIDS, including goals, priorities, information dissemination, and the evaluation of therapies. Go to ARAC.
AIDS Research Review Committee NIAID scientific review group for AIDS grant applications. Go to the AIDSRRC roster.
AIDSRRC See AIDS Research Review Committee.
AITRC See Allergy, Immunology, and Transplantation Research Committee.
ALERT system, PHS

HHS system for disseminating information to Public Health Service officials about organizations or people charged with or found to have engaged in research misconduct. Go to PHS Administrative Actions.

Alien Registration Receipt Card 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. Go to U.S. Citizenship and Immigration Services. Go to NIAID's Foreign Workers on NIH Awards SOP.
Allergy, Immunology, and Transplantation Research Committee NIAID scientific review group for grant applications in allergy, immunology, and transplantation. Go to the AITRC roster.
Allowable cost Cost in a contract that is reasonable, meets accepted accounting principles, is defined in the Federal Acquisition Regulations, or is agreed to by contracting parties. Go to FAR 31 and NIAID's R&D Contracts.
Alterations and renovations Grant budget category referring to work to change the physical characteristics of an existing facility or installed equipment.
Amendment Another term for an application resubmission. See contract modification.
American Indian or Alaska Native Human subjects term indicating a person having origins in the original peoples of North, Central, or South America who maintains tribal affiliation or community.

Human subjects term indicating NIH requirements for human subjects analysis plans. Plans depend on the research proposed and may include monitoring to detect and address adverse effects and intervention differences among groups and subgroups, for example, women, minorities, ethnic or racial groups and subgroups, and children.

Requirements also differ depending on risk and complexity and the probability of finding intervention differences. New and renewal applications and contract proposals must include the results of group and subgroup analyses. Also see valid analysis. Go to Human Subjects.

Animal and Plant Health Inspection Service

Agency of the U.S. Department of Agriculture that protects and promotes U.S. agricultural health and manages activities for wildlife through the Animal Welfare Act.

Investigators who possess or use a select agent must register with and get approval from either the USDA APHIS Agricultural Select Agent Program or CDC Select Agent Program, depending on the agent. Go to NIAID's Select Agent Awards SOP. Go to APHIS.

Animal W elfare Assurance

Document an institution and all performance sites involving animals in research must have on file with Office of Laboratory Animal Welfare before a PHS agency may award a grant or contract. Go to NIAID's Animals in Research SOPs, Vertebrate Animals in Research questions and answers, and Research Animals.

Animals in research

Any live, vertebrate animal used for research, research training, biological testing, or related purposes.

Go to PHS Policy on Humane Care and Use of Laboratory Animals for information and links to legislation and the Office of Laboratory Animal Welfare Animal Welfare Regulations tutorial.

Go to NIAID's Animals in Research SOPs, Vertebrate Animals in Research questions and answers, and Research Animals. See animal welfare assurance.

Animals in research code Number 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 can result in a bar to award. Go to NIAID's Research Animals Involvement Codes on Research Animals.
Anniversary date

See grant anniversary date.


See authorized organizational representative.

APHIS See Animal and Plant Health Inspection Service.
Appeal, grant See grant appeal.
Appeal, peer review Procedure for contesting an initial peer review of a grant application. Synonymous with rebuttal. Go to NIAID's Appeals of Scientific Review of Grant Applications SOP and Should You Appeal? in the NIH Grant Cycle: Application to Renewal.


Supplemental information an investigator may include with a grant application. For more information, go to NIAID's If You Need an Appendix in the NIH Grant Cycle: Application to Renewal.
Applicable Clinical Trials

Applicable drug clinical trial and applicable device clinical trial, used for clinical trial registration on

Applicable drug clinical trial. Controlled clinical investigation, other than a phase I clinical investigation, of a drug that is subject to FDA regulation. See Section 801 of Public Law 110-85.

Applicable device clinical trial. Clinical study of health outcomes that compares an intervention with a device against a control in human subjects (not including small feasibility studies); and pediatric postmarket surveillance. See Section 801 of Public Law 110-85.


Institution applying for a grant. Informally, applicant may also refer to a PI writing a grant application, though the institution is the official applicant.

Application See grant application.
Application Guide See Grant Application Guide.
Application identification number
Application type Activity code Institute Serial no. Suffix year Amendment Supplement
1 R01 AI 183723 01 A1 S1

Number on a grant application identifying the following:

Application package See Grant Application Package.
Application type Broad category of grant application, noted as the first digit on an application identification number.

Law that authorizes federal agencies to obligate funds and make payments from the treasury for specified purposes as well as the amount of money NIH receives. Appropriations are in annual acts and permanent law.

Go to NIAID's tutorial pages starting with Planning and Budget Cycle: NIAID Budget and Planning, Budgets and Planning questions and answers, and Budget and Funding.

Appropriations, continuing See continuing resolution.
ARAC See NIAID AIDS Research Advisory Committee.
Archive date term for the date a funding opportunity announcement expires and moves to the archive. The archive date is different from the closing date. See the equivalent NIH Guide term expiration date.
AREA grant See academic research enhancement award.
Asian Human subjects term indicating 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, or Vietnam.


Child's agreement to participate in research, which is not just a failure to object. Go to definition 45 CFR 46.402, 45 CFR 46.116 general requirements for informed consent, and full 45 CFR 46.
Assignment See receipt, referral, and assignment of grant applications.
Assistance Award of money, property, or services to accomplish a public purpose. Authorized by federal statute, assistance mechanisms such as grants and cooperative agreements are awarded in less detail than acquisitions, such as contracts. Responsibility for performance rests with a recipient or may be shared with the government.
Assistant role for eRA Commons eRA Commons role for someone delegated by a principal investigator to view the status of applications submitted electronically. In the Commons, this role is abbreviated as "ASST," The person in the assistant role can view the same information as the signing official -- he or she can review errors and warnings and can see the application image, but cannot view the summary statement.
ASST See assistant role for eRA Commons.


Written, binding commitment an institution submits to a federal agency promising to comply with human subjects or research animal regulations and stating procedures for achieving compliance. Go to NIAID's Human Subjects, Clinical Research and Research Animals.
Assurance, animal welfare See Animal welfare assurance.
Assurance, human subjects See institutional assurance of protection for human subjects and Federal-wide assurance.
Assurance, Institutional assurance of protection for human subjects See institutional assurance of protection for human subjects.
Assurance, principal investigator signature See principal investigator signature assurance.

Legislation enacted by Congress that sets up or continues the legal operation of a federal program or agency either indefinitely or for a specified time or sanctions an expenditure. An authorization is normally a prerequisite for an appropriation or other budget authority.

Go to NIAID's tutorial pages starting with Planning and Budget Cycle: NIAID Budget and Planning and Budgets and Planning questions and answers.

Authorizations act

Law that establishes or continues federal agencies or programs, establishes terms and conditions under which they operate, authorizes appropriations, and specifies how funds are to be used. Authorizations acts sometimes provide permanent appropriations.

Authorized organizational representative term for an official designated by an organization applying for an NIH award. He or she ensures that the organization complies with terms and conditions and other administrative requirements and is accountable for the use of NIH funds and performance of the research. Go to Grant Application, Electronic SOP.

An AOR may sign an institutional assurance of protection for human subjects and animal welfare assurance, making a commitment on behalf of the institution to meet policy requirements.

NIH may use the term institutional business official instead.

Average programmatic reduction

Dollar amount a grant award is reduced from the amount recommended by a scientific review group in initial peer review. NIAID may make such a reduction in some fiscal years so it can maintain a sufficient number of grants in its portfolio and combat inflation of grant costs.

See financial management plan, and go to NIAID's Budget and Funding, Financial Management Plan SOP, and NIAID Funding Policy and Process SOP.


Legally binding document stating the government has obligated funds, including direct costs and facilities and administrative costs. See also grant and contract.
Award type See activity code.

See Broad Agency Announcement.

Background and Significance

Section of an NIH grant application's Research Plan describing the background, existing state of knowledge, gaps the project is intended to fill, and health relevance of the research. Read Background and Significance in the NIH Grant Cycle: Application to Renewal.

Bar to award

Block to an award of a grant application until problems are resolved, for example, due to insufficient protection of human subjects or research animals. For those concerns, a scientific review group puts a code 44 in the summary statement.

NIAID can also bar an award for unacceptable inclusion of children, women, or minorities.

Also see restriction, and go to NIAID's Bars to Grant Awards SOP. For additional codes, go to NIAID's Human Subjects Inclusion Codes, Human Subjects Involvement Codes, and Animals in Research Involvement Codes.

Go to NIAID's Human Subjects, Clinical Research and Research Animals.

Bayh-Dole Act

Law encouraging universities and researchers to develop their inventions into marketable products.

See Small Business Innovation Research, Small Business Technology Transfer, technology transfer, Federal Technology Transfer Act.

Go to NIAID's Small Business Awards and NIH's Small Business Funding Opportunities.

Belmont Report Statement of ethical principles for human subjects research issued by the National Commission for the Protection of Human Subjects in 1978. Also see Nuremberg Code. Go to the Belmont Report.
Beneficence Ethical principle in the Belmont Reportstating an obligation to protect people by not doing harm, maximizing benefits, and minimizing risks.
Bibliography and References Cited

For electronic grant applications, a field and attachment in the Research and Related Other Project Information component of the SF 424. Go to Other Project Information Form: Bibliography and References Cited in the NIH Grant Cycle: Application to Renewal.

For paper grant applications, Part G., Literature cited, of the PHS 398 Research Plan.

Bilateral agreement General science agreement between the U.S. and a foreign country.
Biographical Sketch

For electronic grant applications, field and attachment in the Research and Related Senior/Key Person Profile component of the SF 424. Go to NIAID's Senior/Key Person Profile Form: Prepare the Biographical Sketches in the NIH Grant Cycle: Application to Renewal.

For paper grant applications, form in the PHS 398 application where the investigator states employment history, relevant publications, and ongoing and completed research support.

Biologic or biological Therapeutic serum, toxin, antitoxin, or analogous product for preventing, treating, or curing disease or injury. Go to 21 CFR 600.
Biological material license

License agreement used when NIH seeks to transfer unpatented, biological materials to a for-profit entity for commercial use. Go to NIAID's Office of Technology Development.

Biomedical Research and Development Price Index Index that enables NIH to measure annual changes in prices of research and development items and services. See also constant dollars and current dollars. Go to NIH's information on the BRDPI. Go to NIAID's Budget and Funding.
Biosafety levels Guidelines for microbiological and medical laboratories that provide levels of protection for workers based on risks of manipulating transmissible agents, using engineering controls, management policies, work practices, and occasionally, medical interventions. Go to CDC's Biosafety in Microbiological and Biomedical Laboratories.
Biosketch See biographical sketch.
Black or African American Human subjects term indicating a person having origins in the black racial groups of Africa.

See biological material license.

Board of Scientific Counselors Body that advises the NIAID Division of Intramural Research director and NIAID director on the Institute's intramural research programs, basing its recommendations on periodic reviews of staff and laboratories. Go to the BSC Roster.
BRDPI See biomedical research and development price index.
Bridge award See R56-Bridge award.
Broad agency announcement

General solicitation that identifies areas of scientific interest or aims to advance science. It differs from an RFP, which specifies a service or product the government wishes to acquire.

Broad agency announcements include criteria for selecting proposals and attracting offerors, who develop a statement of work and performance specifications. Go to NIAID's Broad Agency Announcement Development SOP and R&D Contracts.

BSC See Board of Scientific Counselors.
BSL See biosafety levels.

Budget and Accounting Act


Law requiring the president to send a comprehensive budget for all government agencies to Congress. It mandates OMB to help the president prepare the budget.
Budget appropriation See appropriation.
Budget authority

Legal authority to spend monies for programs, projects, or activities. Budget authority may be classified by the period (one-year, multiyear, no-year), the timing of congressional action (current or permanent), or manner of determining the amount available (definite or indefinite).

Go to NIAID's Budget and Funding and Planning and Budget Cycle: NIAID Budget and Planning.

Budget authorization See authorization.
Budget components, Research and Related See Research and Related Budget components.
Budget, federal See federal budget.

Budget, NIAID

NIAID's annual allotment of funds and plans for spending them. Go to NIAID's Budget and Funding.

Budget pages

For electronic grant applications, see the Research and Related Budget components of the SF 424. Go to NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.

For paper grant applications, see modular budget justification page and detailed budget page.

Budget period See grant budget period.
Budget resolution

Legislation in the form of a concurrent resolution proposing the congressional budget. The resolution establishes budget totals, divides spending into functional categories (e.g., transportation), and may include reconciliation instructions to House or Senate committees.

For electronic grant applications, see the Research and Related Budget components of the SF 424. Go to NIAID's Planning and Budget Cycle: NIAID Budget and Planning tutorial page, Budgets and Planning questions and answers, and Budget and Funding.

Budgetary overlap Overlap of support that occurs when budgetary items requested in a grant application are already provided by another source. Go to NIAID's Prepare Your Other Support Submission in the NIH Grant Cycle: Application to Renewal.
Business official, institutional See institutional business official.

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