For Institute program-specific acronyms, go to NIAID Profile and Fact Book.
For contracts, a statement of an organization's experience, staff, partners, and performance history that may include information on customer needs and how an offeror can satisfy them.
Grant that supports Ph.D.s and clinicians who wish to develop a career in biomedical research; activity codes are in the K series.
Go to these NIAID resources on the Training and Career Awards portal:
Ability of grantees to use grant funds from one budget period in the next one without prior approval from NIAID. This applies to grants covered by 45 CFR Part 74, known as expanded authorities.
Go to the definition in 45 CFR Part 74 and these NIAID resources on the Grant Award and Management portal:
Database of federal assistance programs with program descriptions and contacts. Each has a program number. Go to CFDA.
Formerly used term. See System for Award Management (SAM).
NIH organization that conducts initial peer review of investigator-initiated grant applications for all activity codes (grant types) except those reviewed in institutes.
It also receives all NIH grant applications and assigns them to institutes in some cases for peer review and for administration after award. See Scientific Review Program for the application types NIAID reviews.
Also see study section and integrated review group. Go to the Center for Scientific Review.
Go to these resources on NIAID's Peer Review portal:
HHS agency heading disease prevention and control, environmental health, and health promotion and education. For select agent-related information, see select agent and overlap select agent.
Go to these CDC resources:
HHS agency heading federal health care programs: Medicare, Medicaid, and Children's Health Insurance Program. Go to CMS.
For human subjects, see institutional review board certification.
For research animals, see institutional animal care and use committee certification.
Document that protects investigators and institutions from being forced to release information that would identify research participants. Certificates protect against legal demands for information such as court orders and subpoenas.
Go to NIAID's Certificates of Confidentiality SOP and NIH's Certificates of Confidentiality Kiosk.
Action taken by a grantee that significantly changes aims, objectives, or purposes of an approved project. See scope and prior approval for grants.
Go to NIAID's What Constitutes a Change in Scope? in the Strategy for NIH Funding.
Written order a contracting officer signs directing a contractor to change a contract. For a legal description, see FAR 43.101.
Advisory committee composed mostly of nonfederal experts. Under the Federal Advisory Committee Act, standing committees must be chartered, i.e., approved by the parent agency and the Government Services Agency, to ensure balanced representation for geographical area, women, and diversity and to satisfy other legal requirements.
Go to these resources:
Checklist Form Page
See PHS 398 Checklist form.
Checklist, PHS 398
See PHS 398 Checklist form.
Person under legal age for consenting to research treatments or procedures under the law where the research is conducted. See assent.
NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects requires that children be included in clinical research barring a compelling rationale not to do so.
See human subjects, Planned Enrollment Report and Cumulative Inclusion Enrollment Report.
Act by an offeror to clarify aspects or resolve minor errors of a proposal for a contract. Either an offeror or the government may initiate a clarification. Also see discussion.
Go to FAR 15.306.
FDA classification of medical devices by potential risks. Go to 21 CFR 812.3 and full 21 CFR 812.
Action FDA uses when it deems a clinical trial cannot be conducted without risk to patients. FDA contacts the sponsor within the 30-day initial review period to stop the clinical trial.
FDA may stop an ongoing study based on a review of newly submitted clinical protocols or safety reports.
Research that involves an investigational drug or investigational medical device and human subjects.
Go to the NIAID Human Subjects Resources portal.
Legal requirements NIAID imposes on a clinical research grant. See terms of grant award.
Go to these NIAID resources on the NIAID Human Subjects Resources portal:
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 the NIH Definition of Clinical Trial for a detailed explanation with footnotes.
Clinical trials determine whether new biomedical or behavioral interventions, e.g., investigational drugs or investigational medical devices, are safe, efficacious, and effective.
Behavioral human subjects research involving an intervention to modify behavior (e.g., diet) fits this definition of a clinical trial.
Human subjects research to evaluate a laboratory test may be considered a clinical trial if the test would be used to make a medical decision, or the test entails more than minimal risk for subjects.
Clinical trials usually go through four phases:
Agreement governing the safety and efficacy of outside collaborators' proprietary biologics or pharmaceutical compounds in clinical research.
Go to NIAID's Technology Transfer and Intellectual Property Office.
Monitoring of a clinical trial by a person or group of people who are independent of the research.
Compilation of all regulations issued by the agencies of the federal government and presidential executive orders, which are published in the Federal Register.
The CFR is divided into 50 volumes known as titles. Each title is divided into chapters, subchapters, parts, subparts (in some parts), sections, and paragraphs. Titles are revised at least once a year and issued quarterly.
Individually identifiable private information, such as a person's name or social security number, that is replaced with a code, e.g., number, letter, or symbol.
Investigators are considered to be conducting human subjects research only if they can identify subjects by linking the information to them directly or through a coding system. See investigators for human subjects research, identifier, and personally identifiable information.
License agreement that grants a nonexclusive right to make and use, but not sell, a technology to evaluate its commercial potential for a limited number of months.
Funds used for noncompeting awards, typically 70 to 80 percent of the dollars NIAID spends annually for research project grants.
Go to NIAID's Financial Management Plan on the Paylines and Funding portal.
Overlap of support that occurs when any project-supported personnel have time commitments exceeding 100 percent. See person month.
Go to NIAID's Prepare Your Other Support Submission in the Strategy for NIH Funding.
Subpart A of the Code of Federal Regulations covering protection of human subjects. See 45 CFR Part 46.
Go to the definition in Subpart A of 45 CFR 46—Protection of Human Subjects.
Tuition remission and other forms of compensation (e.g., salary and fringe benefits) paid as, or in lieu of, wages to students, including fellows and trainees.
Compensation may be paid from a research grant or cooperative agreement that does not support an NRSA training grant. The maximum amount allowed is the zero-level Kirschstein-NRSA stipend—go to PI Salary Cap and Stipends. Also see stipend.
Go to these NIAID resources:
Procurement strategy soliciting more than one contractor to submit an offer. An agency's contracting and program officers select an offeror following peer review using technical evaluation criteria.
Go to NIAID's Contracts SOPs and Contracts portal.
Range of qualified offers for a competitive procurement. A contracting officer determines a competitive range based on the ratings of each proposal against all technical evaluation criteria. The competitive range comprises all the most highly rated proposals.
Go to NIAID's Competitive Range for Contracts SOP.
Oral or written communication between the government and an offeror, other than a minor clarification, which enables a contracting officer to determine whether a contract proposal is acceptable or allows an offeror to revise it.
Go to these resources:
Formerly used term. See Research Portfolio Online Reporting Tool (RePORT).
Earliest planning stage of an initiative—request for applications, institute-specific program announcement, or solicitation. NIAID program officers develop concepts and present them to NIAID's advisory Council for concept clearance.
Only some concepts approved by the Council are published as initiatives, depending on their priority and the availability of funds.
Go to these NIAID resources:
Generally performed by NIAID's main advisory Council, a mandatory review of each initiative—request for applications, program announcement, or solicitation.
After hearing presentations from NIAID program officers, Council recommends approval, modification, or deferral of an initiative and advises on the science.
Go to these NIAID resources on the Advisory Council portal:
Ad hoc panel, composed of House and Senate conferees, that reconciles differences in legislation passed by both chambers of Congress. See conference report.
Go to NIAID's Funding Opportunity Planning and the Budget Cycle.
NIAID financial support for scientific meetings, conferences, and workshops in areas related to its mission. Activity codes are R13 and U13.
Go to NIAID's Conference Awards SOP.
Compromise legislation negotiated by a conference committee, which disseminates a conference report to each chamber for its approval or disapproval.
Agreement ensuring that government employees do not publicly disclose a company's proprietary information and that a company does not publicly disclose the government's scientific findings before publication or before the government secures patent rights.
Human subjects term for not divulging information disclosed in a relationship of trust without permission, including fulfilling the expectation that it will remain private. See personally identifiable information.
Financial, career, or other such interest, including interests of family members, that could be advanced by participation on an NIH advisory Council, institutional review board, study section, or other advisory body. See financial conflict of interest.
Legislative Branch office that provides Congress with objective analyses, information, and estimates of the budget and economy that assist the congressional budget process.
CBO presents options and alternatives for Congress to consider but does not make recommendations on policy.
Go to CBO.
Largely verbatim account of proceedings of the Senate printed each day the Senate is in session. At the back of each issue is the "Daily Digest," which summarizes floor and committee activities.
Go to the Congressional Record.
During contract performance, a contracting officer or other authorized government official's oral or written act, which has the same effect as a written change order.
Expert brought into a research project to provide advice, whose participation may be part of a grant's budget.
Go to these NIAID resources in the Strategy for NIH Funding:
Principal investigator who serves as liaison with NIH and sends information to the other PIs of a multiple PI award.
Legislation in the form of a joint resolution enacted by Congress when a new fiscal year is about to begin or has begun, providing budget authority for federal agencies and programs to continue operating until regular appropriations are enacted. Also called continuing appropriations.
Policy that allows members of the following groups to submit R01, R21, and R34 applications any time, regardless of standard receipt dates:
Special rules may apply. Go to these resources:
Award made when a contracting officer signs a contract or notifies a contractor of an award. See contract, R&D.
Go to NIAID's Type of Contract SOP and Contracts portal.
Final actions taken after a contract is completed to certify that all services and deliverables are satisfactory.
Go to NIAID's Closeout SOPs.
NIAID no longer uses this name. See Office of Acquisitions.
Award establishing a binding legal procurement relationship between NIAID and a recipient, obligating the latter to furnish a product or service defined in detail by NIAID and binding the Institute to pay for it. See contract award.
Go to NIAID's Contracts portal.
Requirements in addition to performance requirements, including those defined in a statement of work, specifications, standards and related documents, management systems, and contract terms and conditions of award.
Independent contractor to a sponsor who assumes some of the sponsor's obligations for a clinical trial, e.g., protocol design.
Go to definitions in 21 CFR 312.3 and full 21 CFR 312.
Contracting staff who assists a contracting officer in negotiating and administering contracts.
Go to NIAID's Roles SOPs and Contracts portal.
Written agreement between a grantee and a third party to acquire routine goods and services. See subaward.
Office in an agency authorized to award contracts. See Office of Acquisitions.
Government employee with the authority to enter into, administer, and terminate contracts, including a representative of a contracting officer acting within the limits of his or her authority. Also see contracting officer's representative (COR), and Office of Acquisitions.
Go to NIAID's Contracting Officer SOP.
NIAID staff member who oversees a contract after an award is made. Also see contracting officer.
Go to NIAID's Contracting Officer's Representative (COR) SOP.
Government-titled property acquired or otherwise provided by a contractor for performing a contract.
Go to FAR 45.101.
See other significant contributor.
FDA term for a drug, device, biological, human food additive, color additive, electronic product, or other items regulated by FDA used as a basis for comparison with a test article.
Go to the definitions in 21 CFR 58.3 and full 21 CFR 58.
Grant in the U series that features substantial scientific involvement by NIAID staff.
Go to Cooperative Agreements, U Series and Cooperative Agreements Staff Portal.
Mechanism for collaboration between government and outside scientists that legally defines intellectual property rights and financial and other responsibilities. See technology transfer.
NIH does not use this term. Below is related NIH terminology.
Resource that provides services or facilities to at least two research projects in a multiproject grant.
Go to NIAID's Guidance for Preparing a Multiproject Research Application.
Grant application an applicant fixes after it fails either Grants.gov or eRA Commons validation. Differs from resubmission.
Formerly used term (since NIH eliminated it). See the related viewing window.
Analysis performed by a contracting officer to determine whether an offeror's proposed costs are fair and reasonable.
For a legal description, see FAR 15.404.
See NIH cost management plan.
Cost-reimbursement contract that provides for a negotiated fee fixed at the inception of a contract. The fee does not vary with actual cost but may be adjusted as a result of changes in the work.
This contract type is appropriate for efforts that might otherwise present too great a risk to contractors, but gives them minimum incentive to control costs.
For a legal description, see FAR 16.301-1.
Cost-reimbursement contract that provides for an initially negotiated fee to be adjusted later by a formula based on the relationship of total allowable costs to total target costs. This increase or decrease gives a contractor an incentive to manage a contract efficiently.
Type of contract that provides for payment of allowable incurred costs. These contracts estimate total costs and establish a ceiling a contractor may not exceed except at its own risk without approval of a contracting officer.
Cost-reimbursement contract in which a contractor receives no fee and is reimbursed only for an agreed-upon portion of allowable costs.
For a legal description, see FAR 16.303.
Chartered NIH institute advisory committee that performs second-level review; makes recommendations on funding, policy, and program direction; helps develop concepts; and provides concept clearance for research initiatives. See National Advisory Allergy and Infectious Diseases Council.
Go to NIAID's Advisory Council portal.
Letter attached to a grant application or contract proposal that may request an integrated review group, study section, or institute or provide other information such as documentation of NIAID's preapproval to submit.
A cover letter is required for late and corrected applications. Use the PHS 398 Cover Letter form.
Cover Letter File, PHS 398
Cover Page Supplement, PHS 398
NIH term denoting bribery, fraud, conflict of interest, embezzlement, misuse of funds or resources, perjury; and other violations of criminal law by NIH employees, grantees, contractors, or others doing business with NIH.
The term is used for policies for fraud, waste, and abuse in NIH programs.
Go to NIAID's Reporting Fraud, Waste, and Abuse SOP.
Score that is given by assigned reviewers (e.g., a primary peer reviewer) for each review criterion before an initial peer review meeting and that appears on the summary statement. See critique and overall impact score.
Go to these NIAID resources on the Peer Review portal:
Written evaluation that primary and secondary reviewers (and possibly a reader) prepare before an initial peer review meeting and present to a scientific review group at the meeting.
It recommends an overall impact score (unless not recommended for further consideration) based on scientific merit and addresses the requested budget.
For a renewal, the critique also discusses progress made; for an amended application, it addresses the principal investigator's responses to the critique from the previous review. Also see summary statement.
Go to NIAID's Initial Peer Review in the Strategy for NIH Funding.
Form in a grant application package and PHS 2590 Non-Competing Continuation Progress Report for human subjects research to report participants' sex/gender, race, and ethnicity information. See the Cumulative Inclusion Enrollment Report. Used for progress reports with award dates after October 1, 2014. For progress reports with award dates before October 1, 2014, use the Inclusion Enrollment Report (PHS 2590 forms).
Also see Planned Enrollment Report.
Go to these NIH resources:
current and pending support
Last Updated December 18, 2014
Last Reviewed April 02, 2012