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 point.^[5] The address for that office is:

Center for Scientific Review
National Institutes of Health
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.

Applicants responding to RFAs should submit copies of their application concurrently to CSR and the soliciting IC.

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. Only CSR has the authority to waive an established receipt date.

Legal Implication of Application

The signature of an authorized organizational official on the application certifies that the organization will comply with all applicable assurances and certifications referenced in the application. The applicant organization is responsible for verifying the accuracy, validity, and conformity with the most current organizational guidelines of all the administrative, fiscal, and scientific information in the application, including the facilities and administrative cost (indirect cost) rate. The authorized organizational official's signature further certifies that the applicant organization will be accountable for the appropriate use of any funds awarded and for the performance of the grant-supported project or activities resulting from the application.

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 also is expected to be in compliance with applicable State and local laws and ordinances.

The HHS OIG maintains a post office box and a toll-free hotline for receiving information from individuals concerning fraud, waste, or abuse under HHS grants and cooperative agreements. This information is kept confidential, and callers are not required to give their names. The address and telephone number of the OIG and the OIG Hot Line are included in Part III. Anyone who becomes aware of the existence (or apparent existence) of fraud, waste, or abuse related to NIH grants or grant funds is encouraged to report this information to the OIG in writing or to the OIG Hot Line. Examples of fraud, waste, and abuse that should be reported include, but are not limited to, embezzlement, misuse, or theft of grant funds or property, or making false statements, whether by organizations or individuals. This includes theft of grant funds for personal use; use of funds for non-grant-related purposes; theft of Government-owned property or property acquired or leased under a grant; charging the Government for the services of "ghost" individuals; charging of inflated building rental fees for a building owned by the grantee; submission of false financial reports; and submission of false financial data in bids submitted to the grantee (for eventual payment under the grant).

Part II of this policy statement includes administrative and other remedies the Government may use in the event that a grantee deliberately withholds information or submits fraudulent information or does not comply with applicable requirements. Even if a grant is not awarded, the applicant may be subject to penalties if the information contained in or submitted as part of an application, including its assurances, is found to be false, fictitious, or fraudulent. The Government may pursue civil or criminal action under a variety of statutes and regulations.

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 also may 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 information that is privileged or confidential, the pages containing that information should be identified as specified in the instructions provided in the PHS-398 application kit.

When such information is included in the application, it is furnished to the Government in confidence, with the understanding that the information will 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.

The Peer Review Process

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://www.nih.gov/grants/peer/peer.htm. Information also is available by e-mail at DDER@nih.gov or GrantsInfo@nih.gov, or by calling, writing, or faxing a request to CSR (see Part III).

Initial Review

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.

CSR also may review other types of applications at IC request. When the IC is responsible for the initial review, 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.

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 multi-year 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.

The 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 organizational 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. These procedures call for limited budget information to be submitted with the application (e.g., a budget justification and a modified biographical sketch) and allow for a possible NIH request for additional information, including information concerning other support, when the application is under consideration for funding. "Just-in-time" procedures also allow an applicant to defer certification of Institutional Review Board (IRB) approval of the project's proposed use of human subjects until after completion of the peer review and just prior to funding. (Applications in response to RFAs also may be subject to these procedures. The RFA will specify the timing and nature of required submissions.)

For modular applications, the applicant is not required to submit detailed budget information with the application. In lieu of the standard budget forms, the applicant requests total direct costs for each year of support requested. The request must be accompanied by budget narrative for all personnel (by position, title, and level of effort), including consultants and "to be appointed" positions, and, when applicable, for consortium/contractual costs. NIH will request additional budget information in exceptional circumstances only. "Other support" information will be requested only for modular applications likely to result in an award. (See Part II for more detailed coverage of modular applications and awards.)

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 organizational 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 also will 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 also may 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 also will 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.

National Advisory Council or Board Review

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.

Appeals of Initial Scientific Review

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 official 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 official, who will handle it in accordance with specific appeal procedures.

The program official 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.

Disposition of Applications

All incomplete applications, non-compliant modular 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 changed or 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 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.

Sources of Information about NIH's Grants Process and Programs

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://www.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 Division of Extramural Outreach and Information Resources (at the address shown in Part III).

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://www.nih.gov/grants/oer.htm. The NIH Guide also is available on a subscription basis. For subscription instructions, see http://www.nih.gov/grants/guide/listserv.htm.

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

Computer Retrieval of Information on Scientific Projects (CRISP): an on-line system (https://commons.era.nih.gov/commons/), 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 also are accessible by title at http://www.nih.gov/grants/documentindex.htm. IC Home Pages also should be consulted for IC-specific guidelines (see Part III).

Other documents providing information about or general descriptions of NIH programs also may 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 III for current Web site addresses).

Footnotes for Part I

² Although the government-wide requirements do not cover grants to for-profit organizations, HHS has included them in the coverage of 45 CFR Part 74.

³ The Office of Naval Research is the cognizant agency for negotiation of F&A costs for some NIH grantees

⁴ Some ICs review applications for Institutional National Research Service Awards (T32s) only once per year. See Appendix II-1 in Part II of this policy statement.

⁵ At the present time, NIH is developing and piloting alternative means of electronic submission of applications.