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.

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.

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.

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

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:

• 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, Selection of Appropriate Funding Mechanisms SOP, and Award Types questions and answers.

Administrative change

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.

Go to NIAID's R&D Contracts.

Adverse device 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.

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.

HHS AIDS information site. Go to AIDSinfo.

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.

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.

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.

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.

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.

See grant anniversary date.

See authorized organizational representative.

Appendix

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

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.

Applicant

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

Number on a grant application identifying the following:

• Application type (e.g., new is type 1).
• Activity code (e.g., research project grant is 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 research project 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, a.k.a. administrative supplement -- adds funds to a grant without peer review.
• Type 4 -- Extension -- provides time and funds beyond recommended levels. 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 when one organization buys out another, also called successor of interest.
• Type 7 -- Change of grantee -- transfers a grant from one institution to another.
• 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.

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.

Assent

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.

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 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.

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.

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. Read Background and Significance in the NIH Grant Cycle: Application to Renewal.

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.

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.

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.

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.

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.

See biological material license.

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.

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), 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, 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.

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.

Look It Up

See the Glossary for terms.