NIAID Glossary of Funding and Policy Terms and Acronyms: E-H

Applicant who has completed one of the following within the past 10 years, whichever was later:

• A final research degree.
• Discipline-specific training required to become a researcher.

ESI is a subset of new investigator status, so ESIs must meet those criteria as well. See Are You "New"? Status affects initial peer review and funding decisions.

Go to NIAID's New Investigator Guide to NIH Funding and NIH's New Investigators Program.

Congressional requirement that a federal agency set aside funds within an appropriation for a stated recipient or purpose, for example, to establish a research center grant program or conduct a clinical trial.

NIH database system showing a grant application's summary statement, percentile or priority score or both, scientific review group, program class code, application type, activity code, application identity number, principal investigator, and project title downloaded from IMPAC.

ECB also lets members of NIAID's main advisory Council recommend awards early for fundable applications with no special concerns; see human subjects concern, human subjects codes, and animals in research codes. Go to ECB and NIAID's Electronic Council Book SOP.

System that allows PIs and grantee institutions with awards that have automatic carry over authority to electronically submit a streamlined noncompeting award process progress report. eSNAPs are due 45 days before a noncompeting award's start date.

See expanded authorities and PHS 2590. Go to NIAID's Send Us an Annual Progress Report, eSNAP SOP, and Progress Reports and eSNAP questions and answers.

For paper grant applications only, Form page 5 in the PHS 398 grant application, used to request a budget over $250,000 for a full project period. Also see Detailed Budget for Initial Budget Period. For electronic applications, see Research and Related Budget components.

Go to NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.

For electronic grant applications, result of Grants.gov or eRA Commons validation that stops an application from becoming final -- moving to the Center for Scientific Review.

Errors reflect significant inaccuracies, inconsistencies, omissions, or incorrect formatting. Go to NIAID's About Validations in the NIH Grant Cycle: Application to Renewal and Corrected or Late Electronic Applications questions and answers.

Percentage of increase applicants can request in a competing non-modular grant application to cover annual changes in the price of items and services. It covers personnel costs but not equipment. Also referred to as inflationary factor.

The awarded escalation factor is linked to the Biomedical Research and Development Price Index. See financial management plan and recommended levels of future support and go to NIAID's Budget and Funding.

See early-stage investigator.

NIAID management committee comprising staff from the NIAID Office of the Director, division directors, and other managers.

Executive Committee makes scientific and management policy decisions, allocates resources, establishes grant paylines, approves grant funding plans, and reviews concepts for presentation to NIAID's main advisory Council.

Research excluded from human subjects regulations 45 CFR 46.101. The six human subjects exemptions rarely apply to NIAID-supported researchers because their research is either "human subjects" or "not human subjects."

Go to NIAID's Is Your Research Exempt? tutorial page on Human Subjects, Clinical Research. Also see exemption categories for human subjects research.

FDA term for an IND application filed with FDA, usually by a sponsor. It includes a detailed description of the planned investigation including phase I, II, and III clinical trials and names of investigators and IRB members. FDA has 30 days to review an IND.

Go to definition 21 CFR 312.3 and full 21 CFR 312.

Review of a research project by a designated voting member or members rather than an entire IRB, allowed for some low-risk research and minor changes in approved research. See 45 CFR 46.110. Go to NIAID's Human Subjects Certifications: IRB or IEC SOP on Human Subjects, Clinical Research.

Second-level review of qualifying grant applications by a subset of members of our advisory Council a few weeks after initial peer review to potentially enable NIAID to make awards earlier than usual.

To qualify, an application must be within the payline and have no concerns identified by the study section or Council. Go to NIAID's Advisory Council, NIAID R01 Application to Award Timeline, Expedited Council Review and Award SOP, and Second-Level Review Is Faster for Some Applications tutorial page.

Research supported by NIH through a grant, contract, cooperative agreement, or other funding mechanism to an organization external to NIH. NIAID has three extramural research divisions: Division of AIDS, Division of Allergy, Immunology, and Transplantation; and Division of Microbiology and Infectious Diseases.

See also intramural research. Go to NIAID Research Funding and Extramural and Intramural Research questions and answers.

For electronic applications, see SF 424 (Cover Page) and PHS 398 Cover Page Supplement. Go to NIAID's SF 424 (Cover Page) in the NIH Grant Cycle: Application to Renewal.

For paper grant applications, Form page 1 in the PHS 398 grant application or Form page 1 in a PHS 2590 progress report.

Costs associated with the general operation of an institution and the conduct of its research activities. Formerly indirect costs. HHS supports full reimbursement for F&A costs for most grant programs. Allowable F&A costs include:

• Depreciation use allowance.
• Facilities operations and maintenance.
• General administration and expenses.
• Departmental administration.
• Sponsored project administration.
• Libraries.

See direct cost and go to NIAID's Make Sure Your Institution Has Negotiated F&A Rates in the NIH Grant Cycle: Application to Renewal.

Facilities contract

For electronic grant applications, attachment on the Research and Related Budget Other Project Information form.

Online form every institution and collaborating institution conducting human subjects research must file with the Office for Human Research Protections, HHS, to establish policies and procedures to protect human subjects as required by 45 CFR 46. See institutional assurance of protection for human subjects.

For individuals, see Individual investigator agreement. Go to Electronic Federalwide Assurance and IRB/IEC Registrations. Go to NIAID's Human Subjects, Clinical Research.

Agreed-to amount beyond an initial cost estimate in cost-reimbursement arrangements. A fee may be fixed at the outset of performance, as in a cost-plus-fixed-fee contract, or may vary within a specified range, as in a cost-plus-incentive-fee contract. Go to NIAID's R&D Contracts.

Individual award to students and scientists at predoctoral, postdoctoral, or senior levels; underrepresented groups and the disabled; and postdoctoral trainees in the NIAID Division of Intramural Research to develop careers in biomedical research.

Activity codes are as follows:

• F31, National Research Service Awards for Individual Predoctoral Fellowships to Promote Diversity in Health-Related Research
• F32, Postdoctoral Individual National Research Service Award
• F33, National Research Service Awards for Senior Fellows
• F35, Intramural NRSA Individual Postdoctoral Program Appointee

Go to NIAID's Fellowship Grants SOP, Fellowships questions and answers, Fellowships tutorial page, and Training and Career Awards.

Report showing the status of funds for a grant or cooperative agreement, mandatory for continued funding.

FSRs are due in the Commons at the end of a competitive segment for grants awarded under the streamlined non-competing application process, and 90 days after the end of a budget period for grants not awarded under SNAP. Go to NIAID's File Final Reports at Award End in the NIH Grant Cycle: Application to Renewal.

Contract type that provides for a firm or, in some cases, an adjustable price. Fixed-price contracts with an adjustable price may include a ceiling price, target price, or both.

Unless otherwise specified, these prices can be adjusted only by clauses in a contract. Go to FAR 16.206-1 and NIAID's R&D Contracts.

See funding opportunity announcement.

• Involvement of human subjects or animals in research.
• Extensive foreign travel by grantee project staff for collecting data, surveying, sampling, and similar activities.
• Grant activities that may involve the population, environment, resources, or affairs of a foreign country.

Go to NIAID's Foreign and International Grants and Components SOP and other Foreign SOPs, and International Awards questions and answers.

Percentile or priority score for a grant application that falls within an NIH institute's payline. Go to How NIAID Determines Which Applications to Fund tutorial page, Funding Decisions questions and answers, and Budget and Funding.

Grants.gov notice of a federal grant funding opportunity. NIH FOAs can be RFAs or PAs. Each FOA includes instructions -- a Grant Application Guide, and forms -- a Grant Application Package.

For each FOA, NIH publishes announcements with additional information and instructions in the Guide. Go to NIAID's NIH Funding Opportunities Relevant to NIAID, Funding Opportunity Announcements questions and answers, and Grant Application, Electronic SOP. Also see parent program announcement.

Legislative Branch office that examines the use of public funds to help Congress ensure federal government accountability. GAO performs financial audits, program evaluations, analyses, investigations, and other services.

GAO was formerly known as the General Accounting Office. Go to GAO and GAO Reports.

Financial assistance award from NIAID for peer reviewed research. The grantee is responsible for the research with little or no direct government involvement. NIH generally awards grants to institutions, which must comply with all terms and conditions of award and meet requirements outlined in How to Manage Your Grant Award.

Term covers grants and cooperative agreements. See Notice of Award and go to NIAID's Grants and Contracts, Grant Awards questions and answers, and Application and Awards SOPs.

Based on a grant's start date, basis for funding noncompeting and renewal awards. NIAID cannot fund these awards before their anniversary date. See grant start date.

HHS provision for a grantee institution to address an administrative decision on a grant made by an NIH institute.

There are two levels: an informal NIH procedure and a formal HHS procedure. A grantee must first exhaust informal procedures before appealing to the HHS Appeals Board. Go to NIAID's Appeals of Scientific Review of Grant Applications SOP and Should You Appeal? in the NIH Grant Cycle: Application to Renewal.

Application for financial assistance from a Public Health Service agency to fund biomedical or behavioral research, using the paper PHS 398 or electronic SF 424 forms and instructions.

For help in preparing an NIH grant application, go to NIAID's All About Grants tutorials and NIAID R01 Application to Award Timeline.

Instructions for completing an electronic Grant Application Package. Each funding opportunity announcement has its own package and guide. Go to NIH's Application Guides.

Go to NIAID's NIH Funding Opportunities Relevant to NIAID, Applying for a Grant questions and answers, and Grant Application, Electronic SOP.

Electronic forms applicants complete in response to a funding opportunity announcement that uses electronic application. Each opportunity has its own package, which includes SF 424 R&R forms as well as those called PHS 398, and a Grant Application Guide.

Go to NIAID's NIH Funding Opportunities Relevant to NIAID, Get Ready Now to Apply Electronically tutorial page, Grant Application, Electronic SOP, and Applying for a Grant questions and answers.

Procedure to officially conclude a grant within 90 days after the end of an award. NIAID staff determine whether administrative actions and required work are complete.

A grantee uploads a final financial status report in the eRA Commons and sends the grants management specialist a status of federal cash -- PSC 272, final progress report, and final invention statement -- HHS 568, including any inventions reported previously for that award.

Go to iEdison for invention reporting and NIAID's File Final Reports at Award End in the NIH Grant Cycle: Application to Renewal.

Ability of grantees to move funds from one budget category to another without prior approval from NIH when there is no change of scope. For nonmodular grants, permission is required for some items. Go to NIAID's Grantees Can Take Many Actions Independently and What Constitutes a Change in Scope? in the NIH Grant Cycle: Application to Renewal.

NIAID staff member who interprets and applies grant policies and is the focal point for all business and policy activities, including negotiation, award, and administration of grants and cooperative agreements.

Go to NIH Grants Policy Statement. For Grants Management Program staff, go to GMP Contacts.

Site through which applicants find and apply for grants from many federal agencies. Go to Grants.gov.

Priority score or percentile that falls just outside a payline. NIAID holds applications that fall in the gray zone until the end of the fiscal year for potential funding. Also see deferred.

Go to the How NIAID Determines Which Applications to Fund tutorial page, NIAID's Budget and Funding, and Funding Decisions questions and answers.

Information that NIH or OMB determines could have an impact of more than $500 million in one year on the public or private sector; is novel, controversial, or precedent-setting; or has significant interagency interest.

See influential scientific information and OMB Information Quality Bulletin for Peer Review. Go to the Final Information Quality Bulletin for Peer Review in the Federal Register.

NIAID term for a an infectious agent or toxin that may warrant biosafety level 3 biocontainment or higher according to either the Biosafety in Microbiological and Biomedical Laboratories manual, an investigator's institutional biosafety committee, or a designated institutional biosafety official.

If there is a conflict, the highest level applies. Compare with select agent.

Legally defined term indicating a living person about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information.

Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Go to 45 CFR 46, NIAID's Human Subjects, Clinical Research, Human Subjects questions and answers, How to Write a Human Subjects Application tutorial, and NIH's FAQs about Research Using Human Specimens, Cell Lines or Data.

Defined differently by FDA. See definition 21 CFR 50.3 (g) and subject.

Number a scientific review group places on a summary statement during initial peer review reflecting the application of human subjects regulations to a project as well as the inclusion of women, children, and racial and ethnic populations.

Some codes indicate a human subjects concern that would result in a bar to award. Go to NIAID's Human Subjects Involvement Codes, Human Subjects Inclusion Codes, and Human Subjects SOPs on Human Subjects, Clinical Research.

Look It Up

See the Glossary for terms.