NIAID Glossary of Funding and Policy Terms and Acronyms

Written report from a sponsor notifying FDA and investigators of serious and unexpected adverse events or adverse device effects with an investigational new drug or investigational medical device.

For more information, go to these resources:

• 21 CFR 312.32 (c)
• 21 CFR 812.150 (b)
• NIAID Human Subjects Resources portal

Internal NIAID database that integrates the creation and approval of concepts for subsequent development as a request for application, program announcement, or solicitation, and their scheduling and tracking by fiscal year.

For more information, go to these NIAID resources:

• Scientific Initiative Management System SOP
• Phasing of Initiatives SOP

Formerly used term. See scientific review officer.

Chartered committee performing initial peer review in either the NIH Center for Scientific Review or an institute. SRGs are managed by a scientific review officer.

Institutes review grant applications with their own review requirements. See dual peer review, study section, and integrated review group.

See Scientific Review Program for a list of application types reviewed by NIAID.

For more information, go to these NIAID resources:

• Strategy for NIH Funding
• Peer Review of ApplicationsPeer Review at NIAID questions and answers
• Peer Review portal
• Ensure You Get the Right Assignments in the Strategy for NIH Funding

Federal scientist who presides over a scientific review group and coordinates and reports the initial peer review of each grant application assigned to it.

Scientific review officers act as intermediaries between applicants and reviewers and prepare summary statements for all applications reviewed. See scientific review group.

For more information, go to these NIAID resources:

• Who Peer Reviews Your Application? in the Strategy for NIH Funding
• Peer Review of Applications questions and answers
• Peer Review portal

NIAID organization in the Division of Extramural Activities that oversees initial peer review of grant applications and contract proposals with Institute-specific requirements:

• Program projects (P)
• cooperative agreements (U)
• Training (T) and career development (K) grants
• Contracts (N)
• Investigator-Initiated Clinical Trial Planning and Implementation Awards
• Responses to requests for applications and solicitations

For more information, go to NIAID's Grants and Peer Review portals.

For contact information, go to SRP Contacts. Also see Center for Scientific Review (CSR).

Human subjects term indicating an initial peer review group's determination whether gender and minority representation conform to NIH guidelines and pertain to the science.

A determination of unacceptable bars funding an application or proposal until NIH staff and the principal investigator resolve the issue. Criteria are different for clinical trials and other clinical research.

Scientific parameters of a funded research project. Grantees cannot change the scope of a project without NIAID approval because that would significantly alter the project the peer reviewers and Council recommended for funding.

See prior approval for grants

For more information, go to NIAID's What Constitutes a Change in Scope? in the Strategy for NIH Funding.

Grant application a study section judges to be competitive, generally in the upper half of those being initial peer reviewed. It receives an overall impact score and may be funded by an Institute or center. Also see not discussed.

For more information, go to these NIAID resources:

• Assigning an Overall Impact Score in the Strategy for NIH Funding
• Peer Review of Applications questions and answers
• Peer Review portal

Review generally conducted by an institute's advisory Council that results in funding recommendations to the NIAID or other NIH institute director.

Second-level review looks at program priorities and balance and a lack of barriers to funding such as unresolved human subjects issues. It does not reassess the science. See expedited second-level review and initial peer review.

For more information, go to these NIAID resources:

• R01 Planning to Award Timeline by Review Cycle
• Timing Factors That Affect Your Application and Award in the Strategy for NIH Funding
• Strategy for Second-Level Review in the Strategy for NIH Funding
• Advisory Council portal

Assignment of a grant application by the Center for Scientific Review to an institute or center as a backup for funding should the primary IC decide not to fund it. Either a program officer or applicant can request secondary assignment.

See primary assignment, dual assignment, and receipt, referral, and assignment of applications.

For more information, go to these NIAID resources in the Strategy for NIH Funding:

• Requesting an Institute and Study Section
• Ensure You Get the Right Assignments

Peer reviewer who serves as a backup for a primary peer reviewer. Both read a grant application thoroughly before an initial peer review meeting to lend their expertise to the group discussion. The secondary peer reviewer may also write a critique. See reader.

For more information, go to these NIAID resources:

• SROs Assess Completeness, Assign Reviewers in the Strategy for NIH Funding
• Peer Review of Applications questions and answers

Secure system peer reviewers use to receive electronic reimbursement for expenses and honoraria that result from participating in initial peer review meetings. SPRS is in the Commons.

For more information, go to NIAID's Reimbursement for Peer Reviewers SOP.

Biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant product.

CDC in HHS and Animal and Plant Health Inspection Service (APHIS) in USDA administer the National Select Agents Registry.

U.S. investigators who possess, use, or transfer a select agent must register with and get approval from CDC or APHIS depending on the agent.

As outlined in NIAID's standard operating procedure, both domestic and foreign institutions using select agents are subject to NIAID's select agent terms of award. NIAID also has special procedures for international awards.

Also see dual use research, highly pathogenic infectious agent, NIAID category A, B, and C priority pathogen, overlap select agent, restricted experiment, and USA Patriot Act.

For more information, go to these resources:

• NIAID's Select Agent Awards SOP
• HHS and USDA Select Agents and Toxins List
• National Select Agents Registry Program
• NIH's Select Agent Information
• NIAID's Biodefense and Select Agents portal

For R01 applications at the margin of the payline, the funding of a small number of grant applications that are programmatically important or from investigators who are new, as recommended by NIAID's advisory Council.

Investigators cannot apply for selective pay funding; rather, they are nominated by NIAID program officers. Also called select pay.

For more information, go to these NIAID resources:

• Selective Pay SOP
• R56-Bridge Awards and Selective Pay and Funding Decisions questions and answers
• Contact Your Program Officer to Learn Your Funding Options in the Strategy for NIH Funding
• Paylines and Funding portal

Information that could have a serious adverse effect on a person or an organization's operations or assets if lost, stolen, or tampered with.

Examples include the following:

• Social security numbers.
• Patient and medical information.
• Personally identifiable information.
• Contents of Employee Invention Reports before submission of a patent application.
• Correspondence that includes proprietary information.
• Grant applications and contract proposals.
• Manuscripts not yet been submitted whose contents have not been publicly presented.
• Passwords and access codes.
• Anything protected by the Privacy Act.

Adverse event that results in death, life-threatening experience, hospitalization or prolongation of hospitalization, significant disability, or a birth defect.

Investigators must file serious adverse event reports with a sponsor and institutional review board, which reports them to FDA. IND sponsors must notify FDA and NIAID within 24 hours. If applicable, investigators must also file an FDA Adverse Event Report.

For more information, go to FDA's Adverse Event Reporting System and the NIAID Human Subjects Resources portal.

Monies budgeted for a defined purpose in a fiscal year. NIAID's set-asides include selective pay and R56-Bridge awards. For congressional set asides, see earmark.

For more information, go to these NIAID resources:

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

Instructions for completing an electronic Grant Application Package. Each funding opportunity announcement has its own application package and guide.

For more information, go to NIH's SF 424 (R&R) Application and Electronic Submission Information and these NIAID resources:

• Get Ready Now to Apply Electronically in the Strategy for NIH Funding
• Grant Application, Electronic SOP
• Grant Application portal
• NIAID Funding Opportunities List

Cover page for an electronic Grant Application Package together with the PHS 398 Cover Page Supplement. See funding opportunity announcement. SF 424 also signifies these forms:

• Research and Related Budget Component form
• Research and Related Subaward Budget Attachment form
• Research and Related Other Project Information form
• Research and Related Project/Performance Site Locations form
• Research and Related Senior/Key Person Profile form

For more information, go to these NIAID resources:

• Grant Application portal

See model organism sharing.

Predoctoral trainee supported for a two to three-month training experience, usually in the summer.

1. One of the standard NIH initial peer review criteria used to assess the extent to which a research project addresses an important problem or a critical barrier to progress in its field.

Significance does not evaluate the significance of the field or the ability of investigators to conduct the research. Also see Approach, Innovation, and overall impact score.

2. Section of the Research Strategy in a grant application.

For more information, go to these NIAID resources:

• How NIH Review Criteria Affect Your Score in the Strategy for NIH Funding
• Review Criteria SOP
• Highlight Significance and Innovation and Write the Research Strategy in the Strategy for NIH Funding

See other significant contributor.

Term used in the Commons to denote person with authority to legally bind an institution for grant matters.

In the Commons, signing officials can register an institution, create and modify institutional profile and user accounts, and view all the institution's grants, including status and award data.

Business independently owned and operated and not dominant in its field that meets a size standard.

For more information, go to these resources:

• 13 CFR part 121
• NIH Small Business Funding Opportunities
• NIAID's Small Business Awards portal

Organization that assists and protects the interests of small businesses and helps families and businesses recover from national disasters.

For more information, go to the Small Business Administration.

For-profit business located in the U.S., independently owned and operated, not dominant in its field of operation, and qualified as a small business using criteria in 13 CFR part 121.

For more information, go to 13 CFR part 121 and FAR 19.102.

Government-wide program that promotes R&D with the potential for commercialization at small business concerns.

See NIAID Advanced Technology SBIR, SBIR Fast Track, Small Business Technology Transfer, and Bayh-Dole Act.

For more information, go to these resources:

• Small Business Act
• NIH Small Business Funding Opportunities
• NIAID's Small Business Awards portal

SBIR award that allows concurrent submission and peer review of phase I and phase II grant applications to reduce a potential funding gap between the phases.

For more information, go to these resources:

• Small Business Act
• NIH Small Business Funding Opportunities
• NIAID's Small Business Awards portal

Government-wide program that promotes R&D with the potential for commercialization at small business concerns. It differs from Small Business Innovation Research in requiring a formal collaborative relationship with a university or other non-profit research institution.

See Small Business Innovation Research and Bayh-Dole Act.

For more information, go to these resources:

• Small Business Act
• NIH Small Business Funding Opportunities
• NIAID's Small Business Awards portal

Business that is at least 51 percent owned (including publicly owned) by socially and economically disadvantaged U.S. citizens who control its daily business. Companies are certified by the Small Business Administration under Section 8(a) of the Small Business Act.

For more information, go to the Small Business Act.

NIH grant that supports new, small-scale research projects. R03s are awarded for up to two years and are not renewable.

For more information, go to these NIAID resources:

• Small and Exploratory/Developmental Research Grants SOP
• Small and Exploratory/Developmental Research Grants questions and answers
• Other Grant Types portal

Go to NIH's Small Grant Program (R03).

Contracting process to acquire supplies or services after soliciting and negotiating with only one source.

For more information, go FAR 6.303 and NIAID's Contracts portal.

Formal document that elicits proposals for acquisition or financial assistance awards. Includes requests for proposals (RFP) and broad agency announcements (BAA).

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

Process for selecting a contractor after initial peer review.

For more information, go to NIAID's Contracts portal and the Negotiation, Source Selection, and Award SOP.

Committee that reviews final proposals revisions from offerors in the competitive range, resulting in an award recommendation to NIAID.

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

Notices in FedBizOpps that survey the market to determine if there are potential contractors that can satisfy government requirements.

For more information, go to these resources:

• FedBizOpps
• NIAID's Federal Business Opportunities SOP
• NIAID's Contracts portal

Ad hoc initial peer review group with expertise to review a set of research grant applications or contract proposals. See scientific review group, integrated review group, and study section.

For more information, go to NIAID's Peer Review at NIAID questions and answers.

Section of an NIH grant application's Research Plan stating the objectives and milestones of a research project.

For more information, go to NIAID's Explain Your Aims in the Strategy for NIH Funding.

Person or organization that initiates but does not conduct a clinical study, usually a drug or device manufacturer or the research institution that developed a drug.

Sponsors distribute investigational new drugs or investigational medical devices to principal investigators and ensure compliance with regulations, for example, obtaining FDA approval to conduct a clinical trial and reporting results to FDA.

For more information, go to FDA and 21 CFR 812.3.

Negotiated contract usually between an academic institution and a private corporation giving the institution financial support in return for an option for the company to license patentable items stemming from the research.

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

Cell that can divide indefinitely in cell culture and produce specialized cells. Usually derived from an early embryonic stem cell or embryonic germ cell, but certain types can be derived from adult cells. For policy term, see human embryonic stem cell.

See multipotent, oligopotent, pluripotent, totipotent, and unipotent stem cells.

For more information, go NIH Stem Cell Information and the NIAID Human Subjects Resources portal.

Student financial support for living expenses on National Research Service Award (NRSA) training grants and fellowships. Grantees may supplement stipends from non-federal funds only. Also see compensation.

For more information, go to these NIAID resources:

• PI Salary Cap and Stipends
• Salaries and Stipends questions and answers
• Training and Career portal

Called SNAP, streamlined process to submit a PHS 2590 Non-Competing Continuation Progress Report. A Notice of Award states whether a grant is awarded under SNAP. Also see eSNAP.

For more information, go to these resources:

• NIH's PHS 2590
• NIAID's Noncompeting Progress Reports and Program Officer Approval SOP
• NIAID's Progress Reports and eSNAP questions and answers
• NIAID's Grant Award and Management portal

Practice through which grant applications judged unanimously by peer reviewers as unlikely to be funded are not discussed and do not receive an overall impact score.

These are roughly in the bottom half of applications being reviewed, though the percentage varies by study section and grant type. NIH sends the investigator the primary and secondary reviewers' initial scores and critiques as feedback.

Formerly called triage. Also see recommended, not discussed, and summary statement.

For more information, go to these NIAID resources:

• Noncompetitive Applications Get a Streamlined Review and Part 6. If Not Funded in the Strategy for NIH Funding.
• Peer Review portal

Component of an integrated review group of the NIH Center for Scientific Review that conducts initial peer review in a designated scientific area.

Composed of scientific experts, study sections are managed by CSR scientific review officers. Also called scientific review group. See initial peer review and dual peer review.

For more information, go to these resources:

• CSR Study Section Roster Index
• NIAID's Requesting an Institute and Study Section in the Strategy for NIH Funding
• NIAID's Peer Review of Applications questions and answers
• NIAID's Peer Review portal
• Ensure You Get the Right Assignments in the Strategy for NIH Funding

Collaborative arrangement between a grantee institution and one or more participating profit or nonprofit institutions in support of a research project. Also known as consortium agreement.

For more information, go to these NIAID resources:

• Subawards for Grants SOP
• Consultants or Collaborators—How They Differ and Where to Add Consortium and Contractual Information in the Strategy for NIH Funding

Healthy person or patient who participates in a clinical investigation of an investigational drug or investigational medical device or who is a control.

For more information, go to these resources:

• 21 CFR 312.3
• 21 CFR 812.3
• NIAID Human Subjects Resources portal

Invention defined by the Bayh-Dole Act as emanating from government funding conceived of or first reduced to practice under an award.

For more information, go to 37 CFR 401.2 and full 37 CFR 401.

For electronic grant applications, date Grants.gov must receive the application, same as receipt date. 

For paper applications, date by which an applicant must mail an application to (not date received by) the Center for Scientific Review, which differs from the receipt date. 

Submission date also differs from closing date.

For more information, go to these resources:

• NIH's Submission Policies section of Standard Due Dates for Competing Applications
• NIAID's Prepare to Submit in the Strategy for NIH Funding

Human subjects term indicating a group further defined by geographic origins, national origins, or cultural differences. Subpopulation data can be defined and reported by self-reporting or other means.

Mixed racial or ethnic descent also applies to subpopulations, and such combinations may have biomedical or cultural implications for the science.

Roughly the number of grant applications funded by an NIH institute divided by the number of applications referred to it that were peer reviewed. Applications resubmitted during the fiscal year are counted only once.

For more information, go to NIAID's Strategy for Funding Decisions in the Strategy for NIH Funding.

Official document showing the outcome of initial peer review, including overall impact score (and percentile for an R01), codes if there are areas of concern (e.g., a human subjects concern), and a recommended budget.

Most summary statements also have a short synopsis prepared by a scientific review officer based on peer reviewer critiques.

For more information, go to these NIAID resources:

• In the Strategy for NIH Funding
  • Know What a Summary Statement Means
  • Assess Peer Review Results
• Peer Review portal

Noncompeting—money NIAID adds to an existing grant, including research supplements and administrative supplements.

Competing—now called revision; adds funds to a grant to expand its scope or meet needs of a research protocol following a competing application.

For more information, go to NIAID's Supplements to Grants questions and answers and Research Supplements portal.

See research supplement to promote diversity in health-related research.

See research supplement.

Monies added to a budget appropriations bill. Supplemental funds bolster an existing appropriation deemed insufficient by Congress or pay for activities not covered by an appropriation.

For more information, go to these NIAID resources:

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