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

Applicant who is within 10 years of either of the following:

• 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. ESI status affects initial peer review and institute funding decisions.

For more information, go to these resources:

• NIH's New and Early Stage Investigator Policies
• NIAID's Are You "New"?
• NIAID's New Investigator Guide to NIH Funding
• NIAID's Early-Stage and New Investigators portal

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 downloaded from IMPAC that showsthe following information about a grant application:

• summary statement
• percentile or overall impact/priority score or both
• scientific review group
• program class code
• application type
• activity code
• application identity number
• principal investigator
• project title

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.

For more information, go to these resources: ECB and NIAID's Electronic Council Book SOP.

Information technology infrastructure that enables NIH and other federal agencies to electronically receive, review, and administer grants. eRA enables NIH and its grantees to have an online dialogue throughout the life cycle of a grant. Go to eRA. Also see eRA Commons.

Process that allows principal investigators and grantee institutions with awards that have automatic carryover 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.

For more information, go to these NIAID resources:

• Send Us an Annual Progress Report in the NIH Grant Cycle
• eSNAP SOP
• Progress Reports and eSNAP questions and answers

Invention report due to NIAID within two months after an investigator gives written disclosure to an organizational official.

For more information on grants, go to NIAID's Invention Reporting Has Four Parts in the NIH Grant Cycle.

For more information on contracts, go to NIAID' Invention Reporting for Contracts SOP and NIIH's iEdison.

Concurrence by a full advisory Council or a subset of Council members (or occasionally another group) with an initial peer review group to recommend awards for funding. See second-level review.

For more information, go to NIAID's Council.

Form page 5 in the PHS 398 Grant Application for paper applications used when requesting more than $250,000 or applying from a foreign institution. Also see Detailed Budget for Initial Budget Period.

For smaller budgets, see modular budget. For electronic applications, see Research and Related Budget component form.

For more information, go to these resources:

• Form page 5 in the PHS 398
• NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal

Web-based interface where NIH grantees, staff, and the public access and share administrative information about research awards. Part of Electronic Research Administration, it includes both restricted and public sites.

For more information, go to this resource: eRA Commons.

For electronic grant applications, result of Grants.gov or validation in the NIH eRA Commons. An error stops an application from becoming final and moving to the NIH Center for Scientific Review.

Errors reflect significant inaccuracies, inconsistencies, omissions, or incorrect formatting. See warning.

For more information, go to these NIAID resources:

• About Validations in the NIH Grant Cycle: Application to Renewal
• 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 level of future support.

For more information, go to these NIAID resources:

• Financial Management Plan on Paylines and Funding
• Grant Award and Management portal.

See early-stage investigator.

Standards in contracting used to evaluate an offeror's technical and operational effectiveness.

For more information, go to NIAID's Contracts portal and Technical Review SOPs.

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.

Human subjects term indicating six research categories exempt from human subjects regulations. The six exemptions rarely apply to NIAID-supported researchers.

See exemption for human subjects research. For more information, go to these resources: 45 CFR 46.101 and NIAID Human Subjects Resources portal.

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." See exemption categories for human subjects research.

For more information, go to these NIAID resources: Is Your Research Exempt? in How to Write a Human Subjects Grant Application on NIAID Human Subjects Resources portal.

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 institutional review board members. FDA has 30 days to review an IND.

For more information, go to these resources: 21 CFR 312.3 and full 21 CFR 312.

Specimen or data that are no longer being collected.

For more information, go to these resources:

• NIH's FAQs About Research Using Human Specimens
• NIH's Cell Lines, or Data
• NIAID Human Subjects Resources portal

Legislation providing greater autonomy to grantees, based on regulation 45 CFR Part 74. With the exception of automatic carryover of funds from one budget period to the next, expanded authorities apply to all grants.

For more information, go to these NIAID resources:

• Grantees Can Take Many Actions Independently in the NIH Grant Cycle and Expanded Authorities
• Federal Demonstration Partnership SOP
• Grant Award and Management portal

FDA process that gives access to investigational drugs and investigational medical devices, including treatment investigational new drugs and open study protocols, to people with life-threatening illnesses who are not eligible for a clinical trial and when no other effective therapy exists. Also called compassionate use.

For more information, go to these resources: 21 CFR 312.34 and 21 CFR 312.36.

Adverse event described in package labels, brochures, protocols, and consent forms.

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

Review of a research project by a designated voting member or members rather than an entire institutional review board, allowed for some low-risk research and minor changes in approved research.

For more information, go to these resources:

• 45 CFR 46.110
• NIAID's Human Subjects Certifications: IRB or IEC SOP on NIAID Human Subjects Resources portal

Second-level review of qualifying grant applications by a subset of our advisory Council members a few weeks after initial peer review to enable NIAID to make awards earlier. To qualify, an application must be within the payline and have no concerns identified by the study section or Council.

For more information, go to these NIAID resources:

• Advisory Council
• R01 Application to Award Timeline by Review Cycle
• Expedited Council Review and Award SOP
• Second-Level Review Is Faster for Some Applications in the NIH Grant Cycle: Application to Renewal

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.

For more information, go to these NIAID resources: NIAID Research Funding and Extramural and Intramural Research questions and answers.

For electronic grant applications, see SF 424 (Cover Page) and PHS 398 Cover Page Supplement.

For paper applications, Form page 1 in either the PHS 398 Grant Application or PHS 2590 Non-Competing Continuation Progress Report.

For more information, go to these resources:

• NIAID's SF 424 (Cover Page) in the NIH Grant Cycle: Application to Renewal.
• Form page 1 in NIH's PHS 398 or Form page 1 in the PHS 2590 (paper applications only).

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 costs.

For more information, go to these NIAID resources: Make Sure Your Institution Has Negotiated F&A Rates in the NIH Grant Cycle: Application to Renewal and Grant Award and Management portal.

facilities contract

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

Process FDA uses to accelerate development and review of drugs to treat serious diseases and fill an unmet medical need. Drugs designated as fast track are eligible for accelerated approval and possibly priority review.

These three terms describe FDA's approach to making therapeutically important drugs available sooner.

For more information, go to this FDA resource: Fast Track, Accelerated Approval and Priority Review.

Web site that publicizes federal government procurement opportunities over $25,000.

For more information, go to these resources:

• FedBizOpps.gov
• Federal Business Opportunities SOP
• Contracts portal

Primary authority for government procurement. FAR is published as 48 CFR Chapter 1. Its provisions are implemented and augmented by agency supplements -- see HHSAR.

For more information, go to these resources: HHS Acquisition Regulations and FAR.

Cooperative initiative among federal agencies, including NIH, and outside organizations that receive federal research funding. It conducts demonstration projects that simplify and standardize requirements to increase research productivity and reduce administrative costs.

For more information, go to these resources: FDP and NIAID's Expanded Authorities or Federal Demonstration Partnership SOP.

Official, daily government publication communicating proposed and final regulations and legal notices issued by federal agencies, including announcements of the availability of research funds.

For more information, go to Federal Register.

Law authorizing government agencies to enter into cooperative research and development agreements with private companies. See technology transfer.

For more information, go to these resources: 15 USC 63 Sec. 3710 and NIAID's Office of Technology Development.

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.

An FWA is an institutional assurance of protection for human subjects. For individuals, see Individual investigator agreement.

For more information, go to these resources:

• Electronic Submission System for Federalwide Assurances and IRB/IEC Registrations
• NIAID Human Subjects Resources portal

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.

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

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

For more information, go to these NIAID resources:

• Fellowship Grants SOP
• Fellowships questions and answers
• Fellowships in the Advice on Research Training and Career Awards tutorial
• Training and Career portal

Final contract proposal revision that NIAID asks offerors to submit after negotiations have ended. It documents cost and technical agreements reached during negotiations.

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

Recorded factual material commonly accepted by the scientific community as necessary to document, support, and validate research findings.

For more information, go to NIAID's Data Sharing for Grants: Final Research Data SOP.

Significant financial interests that would likely bias NIAID grantees or contractors. By law, institutions must manage, reduce, or eliminate these conflicts.

For more information, go to these resources: OER's Conflict of Interest and NIAID's Financial Conflicts of Interest for Awardees SOP.

Policy establishing consistency in funding that specifies budget levels for items such as paylines, programmatic reductions, R56-Bridge award levels, and caps for renewal grants. 

For more information, go to these NIAID resources:

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

Report showing the status of funds for a grant or cooperative agreement; FSRs are 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.

For more information, go to NIAID's File Final Reports at Award End in the NIH Grant Cycle: Application to Renewal and Grant Award and Management portal.

Fixed-price contract that cannot be adjusted for a contractor's costs. It provides maximum incentive for a contractor to control costs and perform efficiently and imposes a minimum administrative burden on the contracting parties.

For more information, go to FAR 16.202-1 and NIAID's Contracts portal.

Contract 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. For more information, go to FAR 16.206-1 and NIAID's Contracts portal.

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.

See domestic.

For more information, go to these NIAID resources:

• Foreign and International Grants and Components SOP
• Foreign SOPs portal
• International Awards questions and answers

Private or public nonprofit institution or for-profit organization in a country other than the U.S. and its territories. See domestic.

For more information, go to these NIAID resources:

• International Awards portal
• International Awards questions and answers
• Foreign and International Grants and Components SOP

Process that permits all sources to compete for a contract. See justification for other than full and open competition.

For more information, go to these resources:

• FAR 6.003
• FAR 16.206-1
• NIAID's Contracts portal

Review meeting of a majority of institutional review board members, including at least one nonscientific member. To gain IRB approval, a majority of members present at a meeting must agree.

For more information, go to these NIAID resources:

• Plan for Registering an IRB or IEC in How to Write a Human Subjects Grant Application
• Human Subjects Certifications: IRB or IEC SOP on NIAID Human Subjects Resources portal

Percentile or overall impact/priority score for a grant application that falls within an NIH institute's payline.

For more information, go to these NIAID resources:

• How NIAID Determines Which Applications to Fund in the NIH Grant Cycle: Application to Renewal
• Funding Decisions questions and answers
• Paylines and Funding portal

Grants.gov notice of a federal grant funding opportunity. NIH FOAs can be requests for applications or program announcements. Each FOA includes instructions -- a Grant Application Guide, and forms -- a Grant Application Package. See parent program announcement.

For each FOA, NIH publishes announcements with additional information and instructions in the Guide.

For more information, go to these NIAID resources:

• NIH Funding Opportunities Relevant to NIAID
• Funding Opportunity Announcements questions and answers
• Grant Application, Electronic SOP

Human subjects term indicating a classification of research subjects into women and men. In some cases, gender cannot be determined, e.g., for pooled blood samples.

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

Research to study variation across the entire human genome to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.

For more information, go to NIAID's Data Sharing for Grants: Genome-Wide Association Studies SOP.

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. For more information, go to these resources: 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 in Managing Your Grant in the NIH Grant Cycle: Application to Renewal.

Term also includes cooperative agreements, which have substantial government involvement. See Notice of Award.

For more information, go to these NIAID resources:

• Managing Your Grant in the NIH Grant Cycle: Application to Renewal
• Grants and Contracts portal
• Grant Awards questions and answers
• 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 about a grant by an NIH institute. There are two levels: an informal NIH procedure and a formal HHS procedure. A grantee must first exhaust the informal process before appealing to the HHS Appeals Board. Differs from appeal of peer review.

For more information, go to these resources:

• HHS
• HHS Appeals Board

Application for financial assistance from a Public Health Service agency to fund biomedical or behavioral research, using the paper PHS 398 Grant Applicationor electronic Grant Application Package for most grant types. Grantees use a PHS 2590 to continue a grant. See receipt date.

For more information, go to these resources:

• PHS 398
• NIAID's All About Grants Tutorials
• NIAID's R01 Application to Award Timeline by Review Cycle

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 Guides and these NIAID resources:

• Get Ready Now to Apply Electronically in the NIH Grant Cycle: Application to Renewal, Grant Application
• Applying for a Grant questions and answers
• Grant Application, Electronic SOP
• NIH Funding Opportunities Relevant to NIAID

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.

For more information, go to these NIAID resources:

• Get Ready Now to Apply Electronically in the NIH Grant Cycle: Application to Renewal, Grant Application
• Applying for a Grant questions and answers
• Grant Application, Electronic SOP
• NIH Funding Opportunities Relevant to NIAID

Procedure to officially conclude a grant within 90 days after it ends. 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 Federal Cash Transaction Report (PSC 272), final progress report, and final invention statement (HHS 568) , including any inventions reported previously for that award.

For more information, go to these resources:

• HHS's DPM Secure Systems Login
• HHS 568 form
• NIH's iEdison for invention reporting
• NIAID's File Final Reports at Award End in the NIH Grant Cycle: Application to Renewal
• NIAID's Grant Award and Management portal

Year following the first year of funding of a grant's competitive segment, during which a principal investigator applies for a noncompeting continuation award. See streamlined noncompeting award process.

For more information, go to these NIAID resources:

• Financial Management Plan for funding policies
• Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal

Total period a project has been recommended for support, which may include more than one competitive segment. For example, a project period for a grant begun in 2000 can be divided into these competitive segments: 2000 to 2004, 2004 to 2008, and 2008 to 2012.

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.

For more information, go to these NIAID resources in the NIH Grant Cycle: Application to Renewal:

• Grantees Can Take Many Actions Independently
• What Constitutes a Change in Scope?

Official date a grant begins; same as the first day of the first grant budget period. Also see grant anniversary date.

For more information, go to NIAID's Early Grant Awards questions and answers.

NIAID organization in the Division of Extramural Activities that oversees the business aspects of grants.

For more information, go to NIAID's GMP Contacts.

NIAID staff member who ensures that both the granting agency and grantees meet all requirements of laws, regulations, and policies.

For more information, go to NIAID's GMP Contacts.

NIAID staff member working in the Grants Management Program 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.

For more information, go to these resources:

• NIH Grants Policy Statement.
• GMP Contacts to find staff

Site through which applicants find and apply for grants from many federal agencies.

For more information, go to Grants.gov.

Overall impact/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.

For more information, go to these NIAID resources:

• How NIAID Determines Which Applications to Fund in the NIH Grant Cycle: Application to Renewal
• Paylines and Funding portal
• Funding Decisions questions and answers

Law from 1996 that amends the Internal Revenue Code to improve portability of health insurance coverage, promote medical savings accounts, improve access to long-term care services and coverage, and simplify administration of health insurance.

For more information, go to HIPAA.

Law that provides legislative basis for guidelines for the care and treatment of research animals and oversight by institutional animal care and use committees.

For more information, go to these resources: Health Research Extension Act of 1985 and NIAID's Animals in Research portal.

Department of Health and Human Services codification of uniform acquisition policies and procedures, which implements and supplements the Federal Acquisition Regulation.

For more information, go to HHSAR.

Area of research NIAID emphasizes to prompt grant applications and contract proposals from the extramural research community.

For more information, go to these NIAID Resources:

• Opportunities and Announcements
• Concepts May Turn Into Initiatives and Application Approach: What Are Your Choices?  in the NIH Grant Cycle: Application to Renewal
•  Five Steps to Finding NIAID's High-Priority Areas

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.

For more information, go to 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 of the Centers for Disease Control and Prevention, 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.

For more information, go to CDC's Biosafety in Microbiological and Biomedical Laboratories.

Human subjects term indicating a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

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.

Legally defined term for living persons 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.

Term is defined differently by FDA. See subject.

For more information, go to these resources:

• NIAID Human Subjects Resources portal
• 45 CFR 46
• 21 CFR 50.3 (g)
• NIH's FAQs about Research Using Human Specimens, Cell Lines, or Data
• NIAID's Human Subjects questions and answers
• NIAID's How to Write a Human Subjects Grant Application tutorial

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.

For more information, go to these NIAID resources:

• Human Subjects Involvement Codes
• Human Subjects Inclusion Codes
• Human Subjects SOPs
• NIAID Human Subjects Resources portal

Human subjects term indicating actual or potential unacceptable risk or inadequate protection against risk to human subjects. See human subjects code.

For more information, go to NIAID's Human Subjects SOPs on NIAID Human Subjects Resources portal.