NIAID Glossary of Funding and Policy Terms and Acronyms

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.

For more information, go to definitions in 45 CFR 46.102, full 45 CFR 46, and NIAID Human Subjects Resources portal.

Go to the laws underlying 45 CFR 46:

• Health Research Extension Act of 1985
• Public Health Service Act
• Subparts B, C, and D

See Association for Assessment and Accreditation of Laboratory Animal Care.

For electronic applications, see Project Summary/Abstract and Project Narrative. For paper PHS 398 Grant Applications, see Description.

For more information, go to NIAID's Project Summary/Abstract and Project Narrative in the NIH Grant Cycle: Application to Renewal.

Grant 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.

For more information, go NIH Academic Research Enhancement Award (AREA) Grants and NIAID's Academic Research Enhancement Awards SOP.

Regulation FDA instituted to allow quicker approval of drugs that treat serious diseases and fill an unmet medical need based on a surrogate endpoint -- a marker used as an indirect or substitute measurement that represents a clinically meaningful outcome. FDA uses accelerated approval for drugs designated as fast track.

Accelerated approval, along with fast track and priority review, is part of FDA's approach to making therapeutically important drugs available at an earlier time.

For more information, go to FDA's Fast Track, Accelerated Approval and Priority Review.

acceptable proposal

Contract proposal judged by the majority of a technical evaluation group to be eligible for inclusion in a competitive range or award.

For more information, go to NIAID's Contracts portal.

Obtaining of supplies or services by the federal government with appropriated funds through purchase or lease. For more information, go to NIAID's Contracts portal.

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.

For more information, go to NIAID's Acquisition Planning Resources on the Contracts portal.

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

• F -- fellowships
• K -- career development awards
• N -- research contracts
• P -- program project and research center grants
• R -- research project grants
• S -- research-related programs
• T -- training grants
• U -- cooperative agreements
• Y -- interagency agreements

For descriptions, go to NIAID's Grants portals and Award Types questions and answers.

For staff, go to NIAID's Selection of Appropriate Funding Mechanisms SOP.

administrative change

Unilateral, written change that does not affect rights of the contracting parties. For more information, go to NIAID's Contracts portal.

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.

For more information, go to NIAID's Administrative Supplements to Grants and Cooperative Agreements SOP.

adult stem cell

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.

For more information, go to NIAID's Contracts portal.

adverse device effect

Serious adverse effect on health and safety of human subjects from an investigational medical device. See also unanticipated adverse device effect.

For more information, go to NIAID Human Subjects Resources portal.

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

For more information, go to 45 CFR part 46, subpart A and the NIAID Human Subjects Resources portal.

Occurrence of an adverse effect occurring during a clinical study. Also see serious adverse event.

For more information, go to definitions in 45 CFR part 46, subpart A and NIAID Human Subjects Resources portal.

See Council, advisory and National Advisory Allergy and Infectious Diseases Council.

NIH extramural officer who evaluates the merit of research misconduct allegations and reports findings to appropriate executives. Also see RIO.

For more information, go to NIAID's Research Misconduct Cases SOP.

HHS AIDS information site. For more information, go to AIDSinfo and HHS.

Research of the etiology, epidemiology, natural history, diagnosis, treatment, or prevention of AIDS and its sequelae; does not include all studies of T lymphocytes or retroviruses.

For more information, call a program officer in NIAID's Division of AIDS.

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.

For more information, go to the ARAC roster.

Department of Health and Human Services system for making public the names of organizations and people accused or found guilty of research misconduct.

For more information, go to PHS Administrative Action Bulletin Board of the Office of Research Integrity and NIAID's Research Misconduct Cases SOP.

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.

For more information, go to U.S. Citizenship and Immigration Services and NIAID's Foreign Workers on NIH Awards SOP.

NIAID scientific review group for grant applications in allergy, immunology, and transplantation. For more information, go to the AITRC roster.

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.

For more information, go to FAR 31 and NIAID's Contracts portal.

Alternative term for an application resubmission. For contracts, see contract modification.

Law to stimulate the growth and recovery of the U. S. economy. ARRA gives $1.12 billion to NIAID above its regular appropriation for biomedical research in fiscal years 2009 and 2010. Funds come with additional requirements for grantees.

For more information, go to NIAID and the Economic Recovery Act.

Human subjects term indicating a person having origins in the original peoples of North, Central, or South America who maintains an affiliation with a tribe or community.

NIH policy requires this minority group to be included in clinical research barring a compelling rationale not to do so. See Targeted/Planned Enrollment Table and Inclusion Enrollment Report Table.

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 differ depending on risk, complexity, and the probability of finding intervention differences. New and renewal applications and contract proposals must include the results of group and subgroup analyses. See valid analysis.

For more information, go to the NIAID Human Subjects Resources portal.

Agency of the U.S. Department of Agriculture that ensures the health and care of animals and plants through the Animal Welfare Act.

Investigators who possess or use a select agent must register with and get approval from either the APHIS Agricultural Select Agent Program or CDC National Select Agent Registry, depending on the agent.

For more information, go to these resources:

• APHIS and APHIS Agricultural Select Agent Program
• Biodefense and Biosecurity portal
• CDC National Select Agent Registry
• NIAID's Select Agent Awards SOP

Animal Welfare Assurance

Document an institution and all performance sites involving animals in research must have on file with NIH's Office of Laboratory Animal Welfare before a PHS agency may award a grant or contract.

For more information, go to NIAID's Animals in Research portal.

Live, vertebrate animal used for research, research training, biological testing, or related purposes. See animal welfare assurance.

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

For more information, go to these NIAID resources: How to Write an Application Involving Research Animals tutorial and the Animals in Research portal.

• NIAID's Animals in Research SOPs
• NIAID's Vertebrate Animals in Research questions and answers

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.

For more information, go to NIAID's Research Animals Involvement Codes on the Animals in Research portal.

See grant anniversary date.

See authorized organizational representative.

Procedure for contesting an initial peer review outcome, which NIAID advises against. Synonymous with rebuttal.

For more information, go to these NIAID resources:

• Appeals of Scientific Review of Grant Applications SOP
• Should You Appeal? in the NIH Grant Cycle: Application to Renewal

Appendix

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.

Designation for defining the requirement to register on clinicaltrials.gov.

Applicable drug clinical trial. Controlled clinical investigation, other than a phase I clinical investigation, of an investigational drug subject to FDA regulation.

Applicable device clinical trial. Clinical study of health outcomes (not including small feasibility studies) that compares an intervention with an investigational medical device against a control in human subjects, or pediatric postmarket surveillance.

For more information, go to these resources:

• ClinicalTrials.gov
• Public Law 110-85
• NIAID Human Subjects Resources portal

applicant

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

Number on a grant application identifying the following:

• Application type (e.g., a new application is a type 1).
• Activity code (e.g., a basic research grant is an R01).
• Organization to which an application is assigned (e.g., NIAID is AI).
• Serial number assigned by the Center for Scientific Review.
• Suffix showing the support year (budget period) for a grant.
• Amendment, if resubmitted.
• Other information, e.g., administrative supplement or fellowship institutional allowance.

• Type 1 -- New -- provides PHS support for a new grant.
• Type 2 -- Renewal -- extends a project period that would otherwise expire for one or more grant budget periods; applications are peer reviewed and compete for funding.
• Type 3 -- Supplement -- provides additional funds to a grant as an administrative supplement or revision (aka competing supplement)
• Type 4 -- Extension -- provides time and funds beyond the recommended level. Used only for a few award types.
• Type 5 -- Noncompeting continuation -- continues support in the out years of a grant; does not compete for funds.
• Type 6 -- Change of grantee -- transfers a grant only when one organization buys out another, also called successor of interest.
• Type 7 -- Change of grantee -- transfers a grant from one institution to another (other than Type 6).
• Type 8 -- Change of NIH institute -- transfers a grant from one institute to another.
• Type 9 -- Change of institute -- continues support for grant transferred from one institute to another.

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.

For more information, go to these NIAID resources:

• NIAID Funding Opportunity Planning and the Budget Cycle
• Budgets and Planning questions and answers
• Paylines and Funding portal

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.

NIH policy requires this minority group to be included in clinical research barring a compelling rationale not to do so. See Targeted/Planned Enrollment Table and Inclusion Enrollment Report Table.

assent

Child's agreement to participate in research, which is not just a failure to object. See human subjects.

For more information, go to 45 CFR 46 and definitions in 45 CFR 46.402 and 45 CFR 46.116 General requirements for informed consent.

Private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. For more information, go to AAALAC.

assurance

Written, binding commitment an institution submits to a federal agency promising to comply with human subjects or animals in research regulations and stating procedures for achieving compliance.

For more information, go to these NIAID resources:

• Animals in Research portal
• NIAID Human Subjects Resources portal

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 that sanctions an expenditure. An authorization is normally a prerequisite for an appropriation or other budget authority.

For more information, go to these NIAID resources:

• NIAID Funding Opportunity Planning and the Budget Cycle
• Budgets and Planning questions and answers.

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.

Grants.gov term for an official designated by an organization applying for an NIH grant. 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.

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.

For more information, go to these NIAID resources:

• Grant Application, Electronic SOP
• Application questions and answers

Dollar amount a grant 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 biomedical research and development price index.

For more information, go to these NIAID resources:

• Financial Management Plan SOP
• NIAID Funding Policy and Process SOP
• Paylines and Funding portal

award

See Broad Agency Announcement.

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.

For more information, go to NIAID's Background and Significance in the NIH Grant Cycle: Application to Renewal.

Block to the award of a grant application until problems are resolved. For example, if a scientific review group has concerns about insufficient protection of human subjects or research animals, it enters a code 44 in the summary statement.

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

For more information, go to these NIAID resources:

• Human Subjects Inclusion Codes
• Human Subjects Involvement Codes
• Research Animals Involvement Codes
• Bars to Grant Awards SOP
• NIAID Human Subjects Resources portal
• Animals in Research portal

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

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

For more information, go to these resources:

• Bayh-Dole Act of 1980
• NIH's Small Business Funding Opportunities
• NIAID's Small Business Awards portal

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.

For more information, go to the Belmont Report.

Ethical principle in the Belmont Report stating an obligation to protect people by not doing harm, maximizing benefits, and minimizing risks.

For more information, go to the Belmont Report.

For electronic grant applications, a field and attachment in the Research and Related Other Project Information component of the Grant Application Package.

For more information, go to NIAID's Other Project Information Form: Bibliography and References Cited in the NIH Grant Cycle: Application to Renewal.

For electronic grant applications, attachment in the Research and Related Senior/Key Person Profile component of the Grant Application Package that highlights the scientific accomplishments of key personnel listed in an application.

For paper applications, form in the PHS 398 application that highlights the scientific accomplishments of key personnel.

For more information, go to these resources:

• NIH Guide
• NIH's Biographical Sketch form in the PHS 398 application
• NIAID's Senior/Key Person Profile Form: Prepare the Biographical Sketches in the NIH Grant Cycle: Application to Renewal

Therapeutic serum, toxin, antitoxin, or analogous product for preventing, treating, or curing disease or injury. For more information, go to the definition in 21 CFR 600.

License agreement used when NIH seeks to transfer unpatented biological materials to a for-profit entity for commercial use.

For more information, go to NIAID's Office of Technology Development.

Index that enables NIH to measure annual changes in prices of research and development items and services. See also constant dollars and current dollars.

For more information, go to these resources:

• NIH's BRDPI
• NIAID's Financial Management Plan on the Paylines and Funding portal

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 intervention.

For more information, go to CDC's The 1, 2, 3's of Biosafety Levels.

Human subjects term indicating a person having origins in the black racial groups of Africa.

NIH policy requires this minority group to be included in clinical research barring a compelling rationale not to do so. See Targeted/Planned Enrollment Table and Inclusion Enrollment Report Table.

For more information, go to the NIAID Human Subjects Resources portal.

See biological material license.

Body that advises the NIAID Division of Intramural Research and NIAID directors on the Institute's intramural research programs, basing its recommendations on periodic reviews of staff and laboratories.

For more information, go to BSC Roster.

General solicitation that identifies areas of scientific interest or aims to advance science. It differs from a request for proposals, 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.

For more information, go to these NIAID resources:

• Broad Agency Announcement Development SOP
• Contracts portal

Budget and Accounting Act

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

For more information, go to these NIAID resources:

• Paylines and Funding portal
• NIAID Funding Opportunity Planning and the Budget Cycle

budget, NIAID

NIAID's annual allotment of funds and plans for spending them. For more information, go to NIAID's Paylines and Funding portal.

budget pages

For electronic grant applications, see the Research and Related Budget components of the Grant Application Package. For paper grant applications, see modular budget justification page and detailed budget page.

For more information, go to NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.

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

For more information, go to these NIAID resources:

• NIAID Funding Opportunity Planning and the Budget Cycle
• Budgets and Planning questions and answers
• Paylines and Funding portal

Overlap of support that occurs when budgetary items requested in a grant application are already provided by another source.

For more information, go to NIAID's Prepare Your Other Support Submission in the NIH Grant Cycle: Application to Renewal.