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ARCHIVED - NIH Grants Policy Statement (10/98)

Part I: NIH Grants-General Information

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GLOSSARY

This glossary defines terms commonly used throughout this policy statement. These definitions may be amplified and additional definitions may be found in other sections of this document and in source documents such as applicable statutes, grants administration regulations, and OMB Circulars.

This glossary also includes a list of commonly used acronyms and other abbreviations.

Application: A request for financial support of a project/activity submitted to NIH on specified forms and in accordance with NIH instructions. See "Application and Review Processes.") for detailed information about the appliction process, including an explanation of the types of applications.

Approved Budget: The financial expenditure plan for the grant-supported project or activity, including revisions approved by NIH as well as permissible revisions made by the grantee. The approved budget consists of Federal (grant) funds and, if required by the terms and conditions of the award, non-Federal participation in the form of matching or cost sharing. The approved budget specified in the initial Notice of Grant Award may be shown in detailed budget categories or as total costs without a categorical breakout. Expenditures charged to an approved budget that consists of both Federal and non-Federal shares are deemed to be borne by the grantee in the same proportion as the percentage of Federal/non-Federal participation in the overall budget.

Authorized Institutional Official: The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards.

Award: The provision of funds by NIH, based on an approved application and budget, to an organizational entity or an individual to carry out an activity or project.

Awarding Office: The NIH Institute or Center responsible for the award, administration, and monitoring of grant-supported activities.

Budget Period: The interval of time (usually 12 months) into which a project period is divided for budgetary and funding purposes.

Competitive Segment: The initial project period recommended for support (up to 5 years) or each extension of a project period resulting from the award of a competing continuation grant that establishes a new competitive segment for the project.

Consortium Agreement: A collaborative arrangement in support of a research project in which some portion of the programmatic activity is carried out through a formalized agreement between the grantee and one or more other organizations that are separate legal entities administratively independent of the grantee.

Contract Under a Grant: A written agreement between a grantee and a third party to acquire routine goods or services.

Cooperative Agreement: A financial assistance mechanism used when substantial Federal programmatic involvement with the recipient during performance is anticipated by the NIH Institute or Center.

Cost Sharing: See "Matching or Cost Sharing."

Direct Costs: Costs that can be specifically identified with a particular project(s) or activity.

Equipment: An article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost per unit that equals or exceeds the lesser of the capitalization threshold established by the organization or $5,000.

Expanded Authorities: The operating authorities provided to grantees under certain research grant mechanisms that waive the requirement for NIH prior approval for specified actions.

Expiration Date: The date signifying the end of the current budget period, after which the grantee is not authorized to obligate grant funds regardless of the ending date of the project period or "completion date."

Facilities and Administrative Costs: Costs that are incurred by a grantee for common or joint objectives and that, therefore, cannot be identified specifically with a particular project or program. These costs were previously known as "indirect costs," and, in most instances, will be referred to in this document as "F&A costs."

Federal Demonstration Partnership: A cooperative initiative among some Federal agencies, including NIH; select organizations that receive Federal funding for research; and certain professional associations. Its efforts include a variety of demonstration projects intended to simplify and standardize Federal requirements in order to increase research productivity and reduce administrative costs.

Federal Institution: A Cabinet-level department or independent agency of the executive branch of the Federal Government or any component organization of such a department or agency.

Financial Assistance: Transfer by NIH of money or property to an eligible entity to support or stimulate a public purpose authorized by statute.

Foreign Organization: An organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed principal investigator.

For-Profit Organization: An organization, institution, corporation, or other legal entity that is organized or operated for the profit or financial benefit of its shareholders or other owners. Such organizations are also referred to as "commercial organizations."

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH awarding office anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.

Grant-Supported Project/Activities: Those programmatic activities specified or described in a grant application or in a subsequent submission(s) that are approved by an NIH Institute or Center for funding, regardless of whether Federal funding constitutes all or only a portion of the financial support necessary to carry them out.

Grantee: The organization or individual awarded a grant or cooperative agreement by NIH that is responsible and accountable for the use of the funds provided and for the performance of the grant-supported project or activities. The grantee is the entire legal entity even if a particular component is designated in the award document. The grantee is legally responsible and accountable to NIH for the performance and financial aspects of the grant-supported project or activity.

Grants Management Officer (GMO): An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. Only GMOs are authorized to obligate NIH to the expenditure of funds and to make changes to approved projects on behalf of NIH. Each NIH Institute and Center that awards grants has one or more GMOs with responsibility for particular programs or awards.

Indirect Costs: See "Facilities and Administrative Costs."

Institute/Center (IC): The NIH organizational component responsible for a particular grant program(s) or set of activities. The designated GMO and Program Official for that program or set of activities are employees of the IC. Use of the terms "NIH IC" or "awarding office" throughout this document to designate a point of contact for advice and interpretation of grant requirements and establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award refers specifically to the IC Grants Management Officer.

International Organization: An organization that identifies itself as international or intergovernmental, has membership from, and represents the interests of, more than one country, without regard to whether the headquarters of the organization and location of the activity are inside or outside of the United States.

Key Personnel: Individuals who contribute in a substantive way to the scientific development or execution of a project, whether or not they receive compensation from the grant supporting that project. The principal investigator is included in this category.

Matching or Cost Sharing: The value of third-party in-kind contributions and the portion of the costs of a federally assisted project or program not borne by the Federal Government. Matching or cost sharing may be required by law, regulation, or administrative decision of an NIH Institute or Center. Costs used to satisfy matching or cost sharing requirements are subject to the same policies governing allowability as other costs under the approved budget.

Misconduct in Science: Fabrication, falsification, plagiarism, or other practices that seriously deviate from those commonly accepted within the scientific community for proposing, conducting, or reporting research. The term does not include honest error or honest differences in interpretations or judgments of data.

Monitoring: A process whereby the programmatic and business management performance aspects of a grant are reviewed by assessing information gathered from various required reports, audits, site visits, and other sources.

Notice of Grant Award: The legally binding document that notifies the grantee and others that an award has been made, contains or references all terms and conditions of the award, and documents the obligation of Federal funds. The award notice may be in letter format and may be issued electronically.

Organization: A generic term used to refer to an educational institution or other entity, including an individual, that receives and/or applies for an NIH grant or cooperative agreement.

Principal Investigator/Program Director/Project Director: An individual designated by the grantee to direct the project or activity being supported by the grant. He or she is responsible and accountable to the grantee for the proper conduct of the project or activity.

Prior Approval: Written approval from the Institute or Center Grants Management Officer required for specified postaward changes in the approved project or budget. Such approval must be obtained prior to undertaking the proposed activity or spending NIH funds.

Program: A coherent assembly of plans, project activities, and supporting resources contained within an administrative framework, the purpose of which is to implement an organization's mission or some specific program-related aspect of that mission. For purposes of this policy statement, "program" refers to those NIH programs that carry out their mission through the award of grants or cooperative agreements to other organizations.

Program Income: Gross income earned by a grantee that is directly generated by the grant-supported project or activity or earned as a result of the award.

Program Official: The NIH Institute or Center official responsible for the programmatic, scientific and/or technical aspects of a grant.

Project Period: The total time for which support of a project has been programmatically approved. The total project period is comprised of the initial competitive segment, any subsequent competitive segment(s) resulting from a competing continuation award(s), and noncompeting extensions.

Real Property: Land, including land improvements, structures, and appurtenances, but not movable machinery and equipment.

Recipient: The organizational entity or individual receiving a grant or cooperative agreement. See "Grantee."

Small Business Concern: A business that is independently owned and operated and not dominant in its field of operation; has its principal place of business in the United States and is organized for profit; is at least 51 percent owned, or in the case of a publicly owned business, at least 51 percent of its voting stock is owned by U.S. citizens or lawfully admitted permanent resident aliens; has, including its affiliates, not more than 500 employees; and meets other regulatory requirements established by the Small Business Administration at 13 Code of Federal Regulations (CFR) Part 121.

State Government: The government of: any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, any U.S. territory or possession, or any agency or instrumentality of a State exclusive of local governments. For purposes of NIH grants, federally recognized Indian tribal governments are generally considered State governments. State institutions of higher education and State hospitals are not considered State governments for purposes of the Department of Health and Human Services' general administrative requirements for grants and this policy statement.

Stipend: A payment made to an individual under a fellowship or training grant in accordance with preestablished levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee.

Substantial Foreign Component: Under a grant to a domestic institution, the performance of any significant element or segment of the project outside of the United States, either by the grantee or by a researcher employed by a foreign institution, with or without grant funds.

Suspension: Temporary withdrawal of a grantee's authority to obligate grant funds, pending either corrective action by the grantee, as specified by NIH, or a decision by NIH to terminate the award.

Termination: Permanent withdrawal by NIH of a grantee's authority to obligate previously awarded grant funds before that authority would otherwise expire, including the voluntary relinquishment of that authority by the grantee.

Terms and Conditions of Award: All legal requirements imposed on a grant by NIH, whether based on statute, regulation, policy, or other document referenced in the grant award, or specified by the grant award document itself. The Notice of Grant Award may include both standard and special conditions that are considered necessary to attain the grant's objectives, facilitate postaward administration of the grant, conserve grant funds, or otherwise protect the Federal Government's interests.

Total Project Costs: The total allowable costs (both direct costs and facilities and administrative costs) incurred by the grantee to carry out a grant-supported project or activity. Total project costs include costs charged to the NIH grant and costs borne by the grantee to satisfy a matching or cost sharing requirement.

Withholding of Support: A decision by NIH not to make a noncompeting continuation award within the current competitive segment.

CFRCode of Federal Regulations
CSRCenter for Scientific Review
DCADivision of Cost Allocation
EAExpanded Authorities
F&AFacilities and Administrative (costs)
FCTRFederal Cash Transactions Report (SF-272)
FDPFederal Demonstration Partnership
FSRFinancial Status Report (SF-269 or 269A)
GMOGrants Management Officer
HHSDepartment of Health and Human Services
ICInstitute or Center
NGANotice of Grant Award
NIHNational Institutes of Health
NIHGPSNational Institutes of Health Grants Policy Statement
NRSANational Research Service Award
OEROffice of Extramural Research
OFMOffice of Financial Management
OIGOffice of the Inspector General
OMBOffice of Management and Budget
OPERAOffice of Policy for Extramural Research Administration
OPRROffice for Protection from Research Risks
ORIOffice of Research Integrity
PAProgram Announcement
PIPrincipal Investigator/Program Director/Project Director
PMSPayment Management System
POProgram Official
RFARequest for Applications
SBIRSmall Business Innovation Research Program
SNAPStreamlined Noncompeting Award Process
STTRSmall Business Technology Transfer Program

This section provides information about how NIH is organized to award and administer grants and describes its relationship to other organizations both within the Department of Health and Human Services (hereafter referred to as "HHS" or the "Department") and external to HHS.

NIH is an organizational component of HHS, the mission of which is to improve human health by increasing scientific knowledge related to disease and health. NIH operates under the general policy guidance of the Department in carrying out its mission, which is accomplished through the conduct and support of biomedical and behavioral research, research training, research infrastructure, and communications. These efforts take place intramurally (primarily at NIH) and extramurally (through grants, cooperative agreements, and contracts awarded to institutions of higher education, governmental organizations, non-profit research organizations, for-profit organizations, and individuals). NIH also works closely with other HHS components1 and other Federal departments and agencies.

NIH is organized into Institutes and Centers (ICs), each with its own mission and functions, separate appropriations, and statutory authorities. The ICs that award grants and their points of contact are listed in Part IV. Although these ICs operate under the same general grant process and requirements, there may be differences of which applicants and grantees need to be aware. This information may be obtained from NIH staff. The policies and procedures generally applicable to NIH grants are set forth in this NIH-wide policy statement.

At the Departmental level, HHS develops, issues, and maintains regulations that govern the HHS grants process. Among these are the regulations that implement the OMB Circular A-102 common rule (applicable to grants to State, local, and Indian tribal governments) and OMB Circular A-110 (applicable to grants to institutions of higher education, hospitals, and other non-profit organizations). These regulations are codified at 45 Code of Federal Regulations (CFR) Part 92 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 45 CFR Part 74 (Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non-Profit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments, and Indian Tribal Governments)2. They provide the standard framework for the terms and conditions of NIH awards as specified in Part II.

The relationship between NIH and its grantees involves those engaged in the scientific or technical aspects of the work as well as those responsible for a variety of support functions. NIH, as a Federal grantor agency, is responsible to Congress and the U.S. taxpayer for carrying out its mission in a manner that not only facilitates research but does so cost-effectively and in compliance with applicable rules and regulations. NIH seeks to ensure integrity and accountability in its grant award and administration processes by relying on a system of checks and balances and separation of responsibilities within its own staff and by establishing a similar set of expectations for grantee operations. Although these roles and responsibilities are ones with which NIH grantees should already be familiar, they assume increasing importance as NIH shifts to a greater reliance on systems compliance and provides greater decision-making authority to grantees.

The following subsections highlight the major functions and areas of responsibility of Federal and grantee staff. NIH recognizes that additional staff members in a number of different organizations may be involved in grant-related activities; however, this section details only the major participants representing the Government and the grantee. The responsibilities of those NIH staff members in the Center for Scientific Review (CSR) involved only in the initial peer review process are described in the "Application and Review Processes" section. The responsibilities of other offices, such as the Office for Protection from Research Risks, are described in Part II.

Grants Management Officer: The Grants Management Officer (GMO) whose name appears on the Notice of Grant Award is the NIH official responsible for the business management and other non-programmatic aspects of the award. These activities include, but are not limited to, evaluating grant applications for administrative content and compliance with statutes, regulations and guidelines; negotiating grants; providing consultation and technical assistance to applicants and grantees, including interpretation of grants administration policies and provisions; and administering and closing out grants. The GMO is an employee of the NIH IC that makes the award and is responsible for the efforts of IC grants management specialists. The GMO also works closely with his or her counterparts in other NIH ICs and with the designated Program Official. The GMO is the focal point for receiving and acting on requests for NIH prior approval or for changes in the terms and conditions of award and is the only NIH official authorized to obligate NIH to the expenditure of funds or to change the funding, duration, or other terms and conditions of award.

Grants Management Specialist: The Grants Management Specialist is an agent of the GMO and is assigned responsibility for the day-to-day management of a portfolio of grants.

Program Official: The Program Official is the IC employee responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. Program Officials' responsibilities include, but are not limited to, development of research and research training programs to meet the IC's mission; coordination with CSR/IC Scientific Review Administrators; and postaward administration, including review of progress reports, participating in site visits, and other activities complementary to those of the IC GMO. The Program Official and the GMO work as a team in many of these activities.

Scientific Review Administrator: The Scientific Review Administrator (SRA) is a health science administrator that manages the activities of a scientific review group, including CSR study sections. The SRA performs an initial review of applications for completeness and conformity to requirements, ensures that adequate numbers of reviewers with appropriate expertise are available for application review, assigns applications to individual reviewers as discussion leaders and for preparation of written critiques, and serves as the overall point of contact with applicants during the initial phase of the peer review process; i.e., until the conclusion of the scientific review group meeting.

Other NIH and HHS Staff: The grantee may be required to interact with other NIH or HHS staff/offices, in addition to the IC GMO and Program Official, with respect to its organization-wide systems and/or individual transaction(s). These include the office responsible for negotiation of F&A costs and research patient care rates, typically the cognizant (based on geographical location) HHS Division of Cost Allocation office or the Office of Contracts Management, NIH3; the Division of Payment Management; the Office of the Inspector General; the Office for Protection from Research Risks, and the Office of Research Integrity. Staff in these offices generally coordinate with the GMO, but they are responsible for discrete areas of specialization and are not required to channel their communications with the grantee through the GMO. Part IV includes a list of these organizations and their addresses and telephone numbers.

Authorized Institutional Official: This official is the designated representative of the grantee organization in matters related to the award and administration of its NIH grants, including those that require NIH approval or changes in award terms and conditions. In signing a grant application, this individual indicates the applicant organization's intent to comply with all applicable terms and conditions of award, including assurances and certifications referenced in the application, and attests to the fact that the administrative, fiscal, and scientific information in the application is true and complete and in conformance with governing Federal and organizational requirements. This individual's signature on the grant application further assures that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application. (See also "Legal Implication of Application".) This individual is also responsible to NIH for ensuring that the organization complies with the terms and conditions of individual awards and organization-wide requirements, such as financial management and property management requirements. NIH does not specify the organizational location or full set of responsibilities for such an official; however, it requires the designation of such an official as the focal point for the organization's responsibilities as the grantee.

Principal Investigator: The principal investigator (PI) (may also be known as "program director" or "project director") is the individual, designated by the grantee, responsible for the scientific or technical aspects of the grant and day-to-day management of the project. The PI must have a formal written appointment with the applicant organization, which must be in the form of an official relationship between the parties, but need not involve a salary or other form of remuneration. The PI is a member of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award. He or she works closely with designated officials within the grantee organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; ensure that Federal support of research findings is appropriately acknowledged in publications, announcements, news programs, etc. (see "Administrative Requirements     Availability of Research Results: Publications and Intellectual Property, Including Unique Research Resources"); and comply with organizational as well as Federal requirements. NIH encourages the PI to maintain contact with the NIH Program Official with respect to the scientific aspects of the project. NIH also encourages the PI to maintain contact with the IC GMO concerning the business and administrative aspects of the award.

NOTE: The concept of co-principal investigators is not formally recognized by NIH. NIH staff conduct official business only with the designated PI and authorized institutional officials.

This subsection provides an overview of the types of grants NIH funds; the ways in which potential applicants can learn about funding opportunities; distinctions among types of applications; application requirements, restrictions, and deadlines; how applications are reviewed and by whom; how results are communicated; and applicant rights. It also lists publications and NIH Web sites that can be accessed for additional information concerning the NIH grants process and programs.

NIH ICs make grant awards under multiple programs and subprogram initiatives and use a variety of support mechanisms. NIH grants may be distinguished by purpose, type of recipient, amount, or other characteristics. One method NIH uses to differentiate the various support mechanisms is activity coding that indicates the category and specific form of support (e.g., R01, F32). The applicability of requirements may vary for different activity codes. Therefore, applicants should consult one or more of the information sources described at the end of this section to become knowledgeable about the variety of NIH grant support available and specific application requirements. Some of these distinctions are also significant for purposes of applying Parts II and III of this policy statement.

In general, NIH grants may be awarded to organizations that are domestic or foreign, public or private, and non-profit or for-profit. Eligible organizations include governments, institutions of higher education, hospitals, individuals and Federal institutions. Any special criteria for applicant eligibility or requirements concerning the qualifications of the principal investigator or other staff will be specified in the program solicitation, program guidelines, or other publicly available documents. Part III includes information on trainee and fellow eligibility.

The following describes the most frequently used types of applications in the NIH grants process and the prefixes NIH uses to distinguish them. With the exception of the "noncompeting continuation application," all of the application types listed below are considered "competing," since they must compete through the peer review process for available funding with other applications submitted. The process and requirements for noncompeting applications are specified in Part II.

  • New Application (Type 1): A request for financial assistance for a project or activity that is not currently receiving NIH support and must compete for support.
  • Competing Continuation Application (Type 2): A request for funding to renew, by one or more additional budget periods, a project period that would otherwise expire.
  • Competing Supplemental Application (Type 3): A request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. The request may specify budgetary changes required for the remainder of the project period as well as for the current budget period.
  • Revised (Amended) Application: An unfunded application that the applicant has modified following initial review and resubmitted for consideration. NIH allows a maximum of two revised applications in the 2-year period dating from submission of the original, unamended application.
  • Noncompeting Continuation Application (Type 5): A request for funding for the second or subsequent budget period within an approved project period.

The preponderance of applications submitted to NIH under the categories of research, and research training and fellowships are for investigator-initiated research and are considered "unsolicited" applications. NIH reviews such applications in three review cycles per year. The schedules for submission, review, and award of competing unsolicited applications are included in the application kit and on the NIH Home Page. Applicants are encouraged to contact the IC from which they plan to seek funding. See Part IV for a list of the IC contact points.

Preliminary contact with the IC is required if an applicant anticipates submitting a single unsolicited (investigator-initiated) application, whether a new, competing continuation, competing supplement, or amended grant application under any NIH support mechanism, with a proposed direct cost budget of $500,000 or more for any one year. This requirement also applies to a group of applications, such as those for clinical trial networks, meeting that threshold in the aggregate even if no single application in the group requests that much. This contact should occur as early in the application development process as possible. Applicants that are uncertain about which IC to contact should contact the Division of Receipt and Referral, CSR (see Part IV). CSR will accept such applications for review only if an IC has agreed to accept the application for consideration and the applicant submits a letter to that effect, with the name of the authorizing IC official, with its application (see "The Peer Review Process " below). An application subject to this policy that does not include the required information in the cover letter accompanying the application will be returned to the applicant without review. This policy does not apply to applications submitted in response to Requests for Applications (RFAs) (see below) but such applications must be responsive to any budgetary limits stated in the relevant RFA or NIH will return them to applicants without review.

NIH may develop areas of high priority or special research interest and use a special solicitation to stimulate submission of applications in those areas. These solicitations are published in the NIH Guide for Grants and Contracts and take one of two forms. NIH uses "program announcements" (PAs) to describe new, continuing, or expanded program interests of an IC or to announce the availability of a new mechanism of support. PAs may be used for any support mechanism described above other than construction awards. Unless otherwise specified in the PA, new applications (and associated competing continuation and competing supplemental applications) submitted in response to PAs are treated as "unsolicited," are subject to the same receipt dates, compete for funding with all other unsolicited applications, and are subject to the standard peer review process. PAs are also used for soliciting applications for programs such as the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which issue announcements annually. Those applications must be received by the date(s) specified in the PAs.

A more targeted solicitation is the Request for Applications (RFA) which may be used to solicit:

  • Grant applications in a well-defined scientific area;
  • Research grant applications for a one-time competition;
  • Construction grant applications; or
  • Applications for cooperative agreements.

RFAs are stand-alone solicitations, and each will provide sufficient information to allow prospective applicants to determine whether to apply, including the amount of funding available, the number of awards anticipated, the deadline date for receipt of applications, and other information describing the nature of the effort desired and the obligations of recipients. For cooperative agreements, the RFA will describe the responsibilities and obligations of NIH and the awardee as well as joint responsibilities and obligations.

To be considered for support, an applicant must be an eligible entity and must submit a complete application in accordance with established receipt dates (i.e., deadlines). Information to be submitted typically includes a project description, budget and budget justification, biographical sketches of key personnel, and other information specified in the application kit, in the solicitation, and/or in program guidelines, if any. Applicants should consult the cost principles and general administrative requirements for grants pertaining to their organizational type in order to prepare the budget and complete other parts of the application. Applicants may be required to provide proof of organizational eligibility (such as proof of non-profit status), trainee or fellow eligibility and citizenship, or other eligibility information. Applications must also demonstrate compliance (or intent to comply), through certifications or other means, with a number of public policy requirements. The more significant of the public policy requirements for the purpose of peer review are those concerning research involving human subjects; inclusion of both genders, members of minority groups and children in clinical research; and research involving live vertebrate animals. Public policy requirements and cost and administrative policies are detailed in Part II.

The required application forms vary by support mechanism and by the type of funding requested. The forms for competing applications are specified in Table 1. The application requirements for noncompeting awards are discussed in Part II.

These forms, other than those for the SBIR/STTR programs, are included in application kits maintained by an organization's office of sponsored research or business office. Application kits are also available from the Office of Extramural Outreach and Information Resources, Office of Extramural Research, NIH, at (301) 435-0714, e-mail at grantsinfo@nih.gov, or mail at the address listed in Part IV. Certain forms (rather than a complete application kit) are available electronically on the NIH Home Page. NIH does not distribute software for computer generation of the application.

The SBIR/STTR applications are included in the SBIR and STTR Phase I grant solicitations, which are available electronically on NIH's "Small Business Funding Opportunities" site on the NIH Home Page. A limited number of hard copies of the SBIR/STTR solicitations is produced. Subject to availability, they may be obtained from the PHS SBIR/STTR Solicitation Office, 13687 Baltimore Avenue, Laurel, MD 20707-5096, telephone: (301) 206-9385, fax: (301) 206-9722, or e-mail: a2y@cu.nih.gov. Each SBIR and STTR Phase I grantee (small business concern) is automatically sent a Phase II application package.

TABLE 1
REQUIRED FORMS FOR COMPETING APPLICATIONS
APPLICATION TITLE
FORM NUMBER
USE
Application for a Public Health Service Grant PHS-398 New, revised, competing continuation, and competing supplemental research project grants and cooperative agreements (other than those under the SBIR and STTR programs), program projects, centers, career development awards, Institutional National Research Service Awards (training grants), and conference grants
Application for Public Health Service Individual National Research Service Award PHS-416-1 Competing applications for fellowships
Application for Public Health Service Individual National Research Service Award Continuation PHS-416-9 Continuation applications for fellowships
Public Health Service Grant Application for Use by: State and Local Government Applicants and Nongovernmental Applicants for Health Services Projects PHS-5161-1, including Standard Form (SF) 424, with budget and assurances applicable to non-construction (424-A and 424-B) or construction (424-C and 424-D) State, local, and Indian tribal government applicants for all types of grants, and nongovernmental applicants for construction grants
Small Business Innovation Research (SBIR) Program Grant Applications PHS-6246-1

PHS 6246-2

Competing applications -- Phase I

Competing applications--Phase II

Small Business Technology Transfer (STTR) Program Grant Applications PHS-6246-3

PHS 6246-4

Competing applications--Phase I

Competing applications--Phase II

Application Receipt Points and Deadlines

All competing applications, whether solicited or unsolicited, are required to be sent or delivered, in the number of copies specified in the application kit or solicitation, to the central NIH receipt point4. The address for that office is:

Center for Scientific Review
National Institutes of Health
Suite 1040
6701 Rockledge Drive, MSC 7710
Bethesda, MD 20892-7710

Preaddressed mailing labels are included in application kits.

If express mail or courier service is used, the zip code should be changed to 20817.

An unsolicited application will be considered to be on time for a particular review cycle if it is received by or mailed on or before the published receipt date for that cycle and a proof of mailing is provided. If the receipt date falls on a weekend or a holiday, the date for receipt/mailing is extended to the next business day.

Under an RFA or a PA, if a solicitation-specific deadline date is included, an application received after the deadline date may be accepted only if it carries a legible proof-of-mailing date assigned by the carrier and that date is no later than 1 week prior to the deadline date.

The established receipt or deadline date will be waived only in extenuating circumstances. A request for a waiver must accompany the application and must explain the basis for requesting a waiver. A waiver will not be considered prior to receipt of the application.

The signature of an authorized institutional official on the application indicates the organization's intent to comply with the laws, regulations, and policies to which a grant is subject, including applicable public policy requirements (see " Public Policy Requirements and Objectives" in Part II). That official is also attesting to the fact that the information contained in the application is true and complete, and in conformance with Federal requirements and the organization's own policies and requirements. Applicants for and recipients of NIH grant funds, whether such funds are received directly from NIH, indirectly under a contract or consortium agreement, or as student assistance under a training grant, are responsible for and must adhere to all applicable Federal statutes, regulations, and policies, including income tax regulations. Questions concerning the applicability of income tax regulations to grant funds should be directed to the Internal Revenue Service (IRS). The applicant is also expected to be in compliance with applicable State and local laws and ordinances.

Part II of this policy statement includes administrative remedies the Government may use in the event that a grantee or its employees submit fraudulent information or do not comply with applicable requirements. Even if a grant is not awarded, the applicant may be subject to penalties if the information contained in an application, including its assurances, is found to be false, fictitious, or fraudulent.

The Program Fraud and Civil Remedies Act of 1986, 31 United States Code (U.S.C.) 3801, provides for the administrative imposition by HHS of civil penalties and assessments against persons who knowingly make false, fictitious, or misleading claims to the Federal Government for money, including money representing grants, loans, or benefits. A civil penalty of not more than $5,000 may be assessed for each such claim. If a grant is awarded and payment is made on a false or fraudulent claim, an assessment of not more than twice the amount of the claim may be made in lieu of damages, up to $150,000. Regulations at 45 CFR Part 79 specify the process for imposing civil penalties and assessments, including hearing and appeal rights.

The Criminal False Claims Act, 18 U.S.C. 287 and 1001, provides for criminal prosecution of a person who knowingly makes or presents any false, fictitious, or fraudulent statements or representations or claims against the United States. Such person may be subject to imprisonment of not more than 5 years and a fine.

The Civil False Claims Act, 31 U.S.C. 2739, provides for imposition of penalties and damages by the United States, through civil litigation, against any person who knowingly makes a false or fraudulent claim for payment, makes or uses a false record or false statement to get a false claim paid or approved, or conspires to defraud the Government to get a false claim paid. A "false claim" is any request or demand for money or property made to the United States or to a contractor, grantee, or other recipient, if the Government provides or will reimburse any portion of the funds claimed. Civil penalties of $5,000 to $10,000 may be imposed for each false claim, plus damages of up to three times the amount of the false claim.

NIH may also administratively recover misspent grant funds pursuant to the authorities contained in 45 CFR Parts 74 and 92.

Confidentiality of Information (Proprietary Information)

Applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, if the application contains information that the applicant organization considers to be trade secrets or information that is commercial or financial, or privileged or confidential, the pages containing that information should be identified as specified in the instructions provided in the PHS-398 application kit.

When information in the application constitutes trade secrets or information that is commercial or financial, confidential or privileged, it is furnished to the Government in confidence, with the understanding that the information shall be used or disclosed only for evaluation of the application. The information contained in an application will be protected by NIH from unauthorized disclosure, consistent with the need for peer review of the application and the requirements of the Freedom of Information and Privacy Acts, which are discussed in " Public Policy Requirements and Objectives" in Part II. However, if a grant is awarded as a result of or in connection with an application, the Government shall have the right to use or disclose the information to the extent authorized by law. This restriction does not limit the Government's right to use the information if it is obtained without restriction from another source.

Competing applications for NIH grants and cooperative agreements, including those for competing continuations and competing supplements, are subject to peer review as required by sections 406 and 492 of the PHS Act or by NIH policy. The peer review system used by NIH, often referred to as the "dual review system," is based on two sequential levels of review for each application, initial review and National Advisory Council/Board review. The NIH peer review process has evolved over the years to accommodate changes in workload, resource constraints, and recommendations of various groups that have studied it. However, the underlying basis for the system-to provide a fair and objective review process in the overall interest of science-has not changed. Information concerning NIH's peer review process may be found at the following Web sites: http://www.csr.nih.gov and http://grants.nih.gov/grants/peer/peer.htm. Information is also available by e-mail at DRGINFO@drgpo.drg.nih.gov or grantsinfo@od.nih.gov, or by calling, writing, or faxing a request to CSR (see Part IV).

The Center for Scientific Review is the receipt point for all competing grant applications submitted to NIH, whether the peer review will be conducted by CSR or by an IC. The primary determining factors in whether CSR or an IC will be responsible for the peer review are the solicitation type, the support mechanism, and/or the program. In general, CSR is responsible for the initial review of research project grant applications (including Academic Research and Enhancement Award (AREA) applications), National Research Service Award (NRSA) fellowship applications, and SBIR/STTR applications, while the ICs handle the initial review of conference grant applications, applications resulting from RFAs, and program project grant applications. However, CSR may review other types of applications at IC request.

CSR Referral Officers, who are senior health science administrators with both research and scientific review experience, assign each application to an IC(s) for potential funding and to a scientific review group for initial review of the scientific merit of the application. These determinations are made on the basis of the application's contents, the Referral Guidelines, and any written request by the applicant organization (accompanying the application) for a specific study section/IC assignment.

Scientific review groups, including CSR study sections, are organized by scientific discipline or current research areas and are managed by health scientist administrators functioning as Scientific Review Administrators. Generally, study sections are chartered groups composed of formally appointed members serving multiyear terms, to which the SRA often adds temporary members or other additional reviewers. Special Emphasis Panels (SEPs) are formed on an ad hoc basis to review applications that cannot be reviewed by a standing review group or study section because they require special expertise or involve other special circumstances.

Those individuals serving on a scientific review group, whether a study section or SEP, are primarily scientists actively engaged in research. NIH's conflict-of-interest and confidentiality of information policies for reviewers are intended to ensure an unbiased review process by minimizing even the appearance of a conflict of interest and by restricting the use of privileged application information.

Within 6 to 8 weeks following the established application receipt date, applicants are notified that the application has been received and are advised of the SRA, scientific review group, and IC assignments. At this time, applicants may request reconsideration of the review group and IC assignment. Once the assignment process is completed, the SRA is the contact for all communication with the applicant until the conclusion of the review group meeting. An applicant may withdraw an application from consideration at any time during the review process. A request to withdraw an application must be signed by the PI and an authorized institutional official. If an application is withdrawn before it enters the review process, CSR will return the application to the applicant. Applications withdrawn by the applicant after the beginning of the formal review may be destroyed by NIH or returned to the applicant at NIH's discretion.

In preparation for the initial review, SRAs review applications to determine whether they are complete, conform to administrative requirements, and contain the information necessary for a detailed review. For each application, they then assign (from among the standing and temporary members) reviewers to write a critique of the application and readers to be prepared to discuss the application in detail. NIH uses "just-in-time" procedures for certain programs and award mechanisms that call for limited budget information to be submitted with the application (i.e., a budget justification and a modified biographical sketch) and for a possible NIH request for additional information when the application is under consideration for funding. (Applications in response to RFAs may also be subject to these procedures. The RFA will specify the timing and nature of required submissions.)

The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. Reviewers are asked to address, in their written comments, the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them, as appropriate, for each application. An application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out work that, by its nature, is not innovative but is essential to move a field forward.

  • Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?
  • Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
  • Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
  • Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PI and other researchers (if any)?
  • Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

While the review criteria are intended for use primarily with unsolicited research project grant applications (e.g., R01s and P01s), including those in response to PAs, to the extent reasonable, they will also form the basis of the review of solicited applications and non-research activities. However, for some activities (e.g., construction grants), the use of these criteria, as stated, may not be feasible. Applications may also be reviewed against specific criteria as stated in RFAs or PAs.

In addition to the above criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following:

  • The adequacy of plans to include both genders, members of minority groups, children, and their subgroups, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated.
  • The reasonableness of the proposed budget and duration in relation to the proposed research.
  • The adequacy of the proposed protection for humans, animals, or the environment to the extent they may be adversely affected by the project proposed in the application.

Following the initial review, the SRA prepares a summary statement for each application reviewed. The summary statement includes the reviewers' written comments, and, for scored applications, a summary of strengths and weaknesses, other summary highlights of the discussion, and a priority score. Summary statements are then provided to the IC's program staff and the PI.

Applicants responding to RFAs submit copies concurrently to CSR and the soliciting IC. CSR reviews the application for completeness, and the scientific review office of the soliciting IC reviews the application for responsiveness to the RFA, coordinates the initial technical review, and prepares the summary statements.

For those applications recommended for further consideration, the summary statements are presented to the assigned IC National Advisory Council or Board (hereafter "Council") for use in the second level of review. Council members include both senior scientists with broad experience and members of the public with general knowledge of, and interest in, the IC's mission. The Council reviews applications not only for scientific and technical merit but also for relevance to the IC's programs and priorities. The Council may concur with the initial review group's recommendation, may decide not to recommend an application on the basis of program or policy considerations, or may recommend deferral of an application and refer it back to the initial review group for re-review. With very limited exception, an application may not be considered for funding unless it has received a favorable recommendation by both the initial review group and the Council.

To preserve and underscore the fairness of the NIH peer review process, NIH has established a peer review appeal system to provide applicants the opportunity to seek reconsideration of the initial review results if, after review of the summary statement, they believe the review process was procedurally flawed ( NIH Guide for Grants and Contracts, Vol. 26, No. 38, November 21, 1997). This appeal process is not intended to deal with differences of scientific opinion between or among investigators and reviewers.

If the applicant has concerns about the conduct of the review, whether the initial review was conducted by CSR or by the IC, the applicant should discuss them with the program administrator responsible for the application, who will attempt to resolve the applicant's concerns. If, after discussion with the program administrator, the investigator still has concerns, he or she may submit a formal letter of appeal to the program administrator, who will handle it in accordance with specific appeal procedures.

The program administrator will consult with the SRA or staff of the IC scientific review office. This consultation may result in a decision to re-review the application. A re-review consists of a review of the same application, not a revised version, by the same or another review group without access to the summary statement of the disputed review. If NIH staff and the investigator cannot agree on a course of action, the appeal will be reviewed by the designated IC Appeals Officer. That official will make the appeal letter available to the Council along with the IC recommendation on the appeal and any written comments from the SRA or review group. The Council may either reject the appeal and let the initial review stand or recommend that the application be re-reviewed. The Council's decision may not be further appealed.

All incomplete applications and those applications determined to be non-responsive to solicitation requirements will be returned to the applicant by CSR or by the IC referral office without further action. For unsolicited applications that are returned, the applicant may resubmit a complete version of the application for consideration in the next review cycle.

Following the initial review, the PI will receive a copy of the summary statement and will be advised by letter from the responsible IC whether the application has been recommended for further consideration by the Council.

The IC Director or designee is the official that has the authority to make final award decisions from among those applications receiving a favorable initial review and Council recommendation. If an application has been recommended for further consideration but is not expected to be funded in the current cycle, the application may be held by NIH for an additional cycle(s) and will compete with other applications submitted for that cycle. If an application is unsuccessful, the applicant may subsequently submit up to two revised versions of the application for review in a future cycle(s), but NIH will not accept a revised application submitted more than 2 years from the receipt of the original application.

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The process leading to an award, including the business management review performed by the IC GMO, is described in Part II. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeals to any NIH or HHS official or board.

As described below, NIH maintains a number of information resources about its grant programs and activities that can be accessed through the Home Page maintained by the Office of Extramural Research. Some are descriptive materials that allow interested parties to learn about NIH grant initiatives, funding opportunities, and proposed and actual policy changes. Others provide historical data. These documents are updated annually or as needed. The NIH Web site address for these materials and other grant-related materials is http://grants.nih.gov/grants/oer.htm (a more specific address may be provided below). In addition, these materials may be requested using e-mail through grantsinfo@nih.gov, by telephone at (301) 435-0714, or by writing to the Office of Extramural Outreach and Information Resources, Office of Extramural Research, 6701 Rockledge Drive, Suite 6095, Bethesda, MD 20892-7910.

These information resources include:

NIH Extramural Programs: a compendium of the scientific programs of the NIH components that award grants, cooperative agreements, and contracts. It indicates current areas of research emphasis, highlights special interests of each IC, and identifies specific NIH offices to be contacted for further information about particular programs, policies, and procedures. The Web site address is http://grants.nih.gov/grants/oer.htm.

NIH Guide for Grants and Contracts: announces new programs and policies, including program announcements, Requests for Applications, and Requests for Proposals. The Web site address for the NIH Guide is http://grants.nih.gov/grants/oer.htm.

Research Grants and Contracts: annual listing of extramural awards, previously known as "the brown book." The Web site address is http://grants.nih.gov/grants/award/award.htm.

Computer Retrieval of Information on Scientific Projects (CRISP): an on-line system, updated quarterly, that provides a brief description of and administrative data on each NIH-funded research project.

Program Guidelines: detailed policy and procedural information applicable to specific programs/activities. NIH-wide program guidelines are published initially in the NIH Guide for Grants and Contracts (see above) and are also accessible by title at http://grants.nih.gov/grants/documentindex.htm. IC Home Pages should also be consulted for IC-specific guidelines (see Part IV).

Other documents providing information about or general descriptions of NIH programs may also be requested. These include Helpful Hints on Preparing a Research Grant Application to the NIH, Helpful Hints on Preparing a Fellowship Application to the NIH, Research Training and Career Development Programs, and NIH Minority Programs. These documents contain useful information but are not currently available on-line and may not provide as up-to-date or complete information as those documents linked to the NIH OER Home Page.

Each IC also maintains its own Home Page accessible through the NIH Home Page submenu entitled "Institutes and Offices" (see Part IV for current Web site addresses).


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