The receipt and referral process is an important aspect of the overall NIH peer review system that considered almost 70,000 applications in fiscal year 2004. The role of the Division of Receipt and Referral (DRR) in the Center for Scientific Review (CSR) is to assign each application to a review group that has the expertise to evaluate the scientific and technical merit of the application and to one or more Institutes/Centers (ICs) for funding consideration. While many NIH policies give authority to the DRR to determine assignments, staff of the DRR engage in dialogs with Institutes/Centers, Scientific Review Administrators and Integrated Review Group (IRG) Chiefs, and applicants to reach an appropriate assignment. This description of the process is divided into three main sections: Submission of the Application, Checking the Application for Compliance with NIH Policies, and Assignment of the Application for Review and Funding Consideration.

Submission of the Application

The DRR is the central receipt point for all new, revised, competing continuation, and competing supplement applications submitted to the NIH whether they are unsolicited or in response to a Request for Applications (RFA). Noncompeting applications (progress reports) are sent to a separate central location and then distributed to the funding Institute or Center.  Contract proposals are sent directly to the soliciting Institute or Center and administrative supplements are sent directly to the Institute or Center that is funding the parent grant. The receipt, referral, review, and award process occurs three times each year. Within each cycle there are numerous receipt dates. For a summary of standing receipt dates, please see http://grants.nih.gov/grants/dates.htm.

Information about grant application submission, links to application forms, policy requirements, and other topics is found at the Office of Extramural Research Grants Home Page:  http://grants1.nih.gov/grants/oer.htm

The NIH is accepting certain kinds of applications via electronic submission.  This process is a system to system exchange involving service providers who have the appropriate computer interface.  The following site provides more details on this process and other electronic research administration initiatives:  http://era.nih.gov/.

Investigators may include a cover letter with their application that addresses the following:

·         The grant mechanism of the application, particularly if it is one of the less commonly used mechanisms.

·         Suggestions regarding the Institutes or Centers that are most likely to be interested in the scientific area being studied; if the investigator has discussed the application with a specific program director, this information should be included.

·         Suggestions regarding the review of the application at the IRG level, the study section level, and/or a list of the scientific areas that are critical to understanding the application. It is very helpful to identify multidisciplinary applications and to make clear what the investigator feels is the main disciplinary or methodological thrust of the application. It is NOT APPROPRIATE to include a list of potential reviewers by name. It is appropriate to mention individuals by name with whom there is a conflict of interest and who should not be considered as reviewers. CSR provides the referral guidelines for assignment to IRGs and Study Sections on the CSR website (http://www.csr.nih.gov/review/irgdesc.htm http://www.csr.nih.gov/review/irgdesc.htm) as a source of information for applicants. Applicants may wish to contact SRAs or the DRR (301-435-0715) with specific questions about a potential assignment

Investigators should use a single package for a grant application, even for very large grant applications. Conversely, inclusion of more than one grant application in a single package may cause problems if the multiple submissions are not recognized. Applications must be delivered by the United States Post Office or a delivery/courier service.  Individuals may not personally deliver their applications to NIH: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html .

Permission is not given in advance for a late submission. NIH has established a window of consideration in which applications must be received in order to have a possibility of acceptance.  All late applications must include a cover letter that provides details on the specific reasons for the delay.  Further information is found in a January 2005 NIH Guide to Grants and Contracts notice:  http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-030.html . As NIH moves to shorten the receipt to award timeframe, the ability to accept late applications likely will be diminished.

If problems (missing pages, incorrect pages included, etc.) are identified after an application has been submitted, investigators must call DRR (301-435-0715) to discuss the specific situation before submitting a corrected version of the application.

Checking the Application for Compliance with NIH Policies

In the initial processing of applications data items from the face page, budget pages, and checklist are entered into a database to create a unique record for each application. If an application is submitted in response to a Request for Applications (RFA) or Program Announcement (PA, PAR, or PAS), the identifying number entered on line 2 is important for subsequent processing of the application; this is required for R03 and R21 applications (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-010.html) .  Omission of information or errors by the applicant may lead to confusion or delays in handling the application.

Processing and assignment of applications in the DRR is the first opportunity to check for compliance with important NIH policies. Among the policy issues that are addressed in the DRR are:

·         Use of the current version of the appropriate application kit.  These are available at the following site:  http://grants1.nih.gov/grants/forms.htm .  The application must be complete and must contain sufficient information for the review group to evaluate the scientific and technical merit of the application

·         The two-amendment limitation: the number of revisions of an application is limited to two.  There is no longer a time limit for the submission of the two revisions:  http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html.   Revised applications must include an Introduction that discusses the previous review, and should mark the text to show where changes have been made

·         Applications submitted in response to a Request for Applications (RFA) are normally new applications.  If an RFA submission is not successful, a subsequent application should be submitted as a new application, not a revision:  http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html.

·         Applications that are changing grant mechanisms should also be submitted as new applications:  http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html

·         Modular budgets: R01, R03, R15, and R21 applications requesting $250,000 or less in direct costs each year must be submitted in modular budget format: http://grants1.nih.gov/grants/funding/modular/modular.htm.

·         Approval is needed for applications requesting over $500,000 direct costs: NIH policy requires that any competing application (new, continuation, revised, supplement) requesting over $500,000 direct costs in any year must be accepted by an Institute or Center prior to assignment for review:  http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.   Investigators need to contact the Institute or Center at least six weeks prior to the submission of the application. 

·         Approval is also needed for conference grant applications:  see http://grants1.nih.gov/grants/funding/r13/index.htm for more information. 

• Applications proposing research on Human Embryonic Stem Cells must indicate the registration number of the cell lines to be used or include a statement that one from the registry will be used on page 2.

·         Format of applications: Applications are checked to make sure that they follow the font style, type size, page limits, margin size and other requirements specified in the application kits.  When noncompliant applications are identified, the investigators may be contacted and asked to correct the problem quickly.  Further checking occurs at the study section and in rare cases noncompliant applications may be deferred for a later review.       Photographs or other images may be included if they are printed directly on the page.  Glossy versions should be included in the appendix. 

·         Inclusion of at least three reference letters for fellowship applications (predoctoral, postdoctoral, and senior fellowships) and mentored research career development award applications.

Other important aspects of a grant application such as information on human subjects research, use of vertebrate animals, and plans for resource sharing are scrutinized at other stages of the grant process.  Applications that do not address all the critical components may be delayed in the review process or for potential funding.

Assignment of the Application for Review and Funding Consideration

Investigators sometimes ask how much of the application is read in making an assignment. The honest answer is as much of the application as needed to make the determination. Referral Officers have access to the entire application, not just the face page and Description on page 2. In many cases, they concentrate on the Description and Specific Aims in making an assignment, with attention also paid to the Significance and Research Methods sections. Requests made by investigators and the assignment of previous applications are also considered.  Some applications are quite easy to assign for both review and Institute/Center consideration while others are more difficult. Referral staff regularly discuss the assignment of applications or how to handle unusual situations. The assignment of a grant application involves a series of decisions.

·         Determination of grant mechanism. There are more than 100 grant mechanisms to support research and research training ranging from individual fellowships through very large center grants. All Institutes and Centers (ICs) use the R01 and F32; a single or only a few ICs use other mechanisms. Mechanisms are identified in the NIH system by a letter and number code; examples include:

For more information see: http://grants.nih.gov/grants/funding/funding_program.htm

·         An institute or center is identified for primary assignment for funding consideration. This determination is based on the focus and mission of each of the twenty-four institutes and centers of NIH. Due to the increasingly multidisciplinary nature of scientific inquiry, the complex biological problems being addressed, and the use of many common research methodologies the ICs share many common interests. The interests of the Institutes and Centers are described on the main NIH web site (http://www.nih.gov/icd/).

Applications may receive primary and dual assignments. Dual assignments acknowledge the shared interests of ICs in a given scientific topic and make all of the appropriate ICs aware of the application. The primary assignment is reflected in the assignment number (CA for the National Cancer Institute, AG for the National Institute on Aging, etc.). When multiple dual assignments are made, a rank order (secondary, tertiary, etc.) is not established. Both the primary and dual Institute/Center receive copies of the application, and summary statement and council consideration is given by both the primary and dual ICs. However, a dual assignment does not necessarily increase the chance of an award. The frequency of a dual assignment leading to a change to primary and award is less than 2%.

·         Finally, the grant application is assigned for review to the CSR or to one of the IC Review groups. CSR reviews most R01s, pre and postdoctoral fellowships, and small business applications. IC review groups handle applications that have Institute-specific features such as program projects, training grants, career development awards, and responses to Requests for Applications.

Within an Institute/Center, a general assignment is made to that IC and the staff in the review unit decides whether the application is to be reviewed by one of their standing committees or by a Special Emphasis Panel. Within CSR, a two-stage process is employed with initial assignment to the IRG (Integrated Review Group, a cluster of scientifically related Study Sections) level and subsequent assignment to a specific Study Section or Special Emphasis Panel. By assigning all applications to the IRG level rather than directly to an individual study section, the IRG Chief and the SRAs within the IRG have the opportunity to gain a broad perspective of the areas of science covered by their IRG and to appreciate changes in emphasis and the emergence of new areas. A number of methods are used to determine assignments within the IRG, though all involve discussions among the SRAs and the Chief. Finally, the IRGs also have the option of suggesting that the application is more appropriate for a different IRG; they may discuss this with other SRAs or IRG Chiefs or return the application to the DRR for reassignment.

Note: The terms Study Section and Review Committee are normally used for continuing review groups in CSR and the ICs, respectively.  These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.  Special Emphasis Panels are review groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs. 

At the completion of the assignment process a letter is sent to both the Principal Investigator and the business office of the applicant institution. This letter should normally be received within six weeks for applications submitted on regular receipt dates and three weeks for applications submitted for expedited dates (fellowships, small business applications, AIDS applications, responses to RFAs).  If a notification is not received in this time period, the investigator should promptly contact the DRR at 301-435-0715. Occasionally there are problems with delivery of applications and if these are discovered early it is much easier to address the problem than if investigators wait many months before checking.

Investigators who are registered on the NIH Commons have electronic access to this and other application information such as the summary statement within days rather than weeks.  See this site for more information on the NIH Commons:  https://commons.era.nih.gov/commons/ .

The assignment letter contains valuable information:

·         The timetable for review and funding consideration.

·          The assignment number which is in the format 1 R01 CA123456-01 and provides
the following information:

o         The type
      1  new application
      2  competing continuation application
      3  supplemental application

o        The mechanism (R01, F32, etc)

o        The Institute/Center with primary assignment (in this example CA stands for
the National Cancer Institute)

o        A unique identifier for the primary institute/center- "123456"

o        The year and any suffix (01 is year 1, A1 indicates the first amendment, A2
the second; S is used for supplement)

·         Any dual assignments are indicated by the two-letter code.

·         The review assignment, including the name of the study section/special emphasis panel and the name, address, and telephone number of the Scientific Review Administrator (SRA). The SRA is now the primary point of contact for the investigator throughout the review process.

·         Information about the primary Institute/Center to which the application is assigned. Since a specific Program Director has not been designated at this time, there is general contact information.

·         The address of the investigator: This is taken from the “Mailing Address” box on the face page of the application. If the address is incorrect or there have been changes in the address since submission, please contact the SRA. This address also will be used for score and summary statement mailings so it is important that it be both complete and accurate. Large institutions have complicated mail delivery systems so investigators should be sure to include building and room numbers, mail codes, street addresses, etc. as needed.

If there are questions about the correctness and appropriateness of the assignment, the investigator should contact the SRA for review questions or the DRR for assignment questions. If a change in assignment is requested, it is most efficient to fax the request to 301-480-1987. The DRR will notify the investigator if the change is not possible. If the review location, primary institute, or timetable for consideration (council round) is changed for an application, a second mailer will be sent noting the change.

Once the application has been assigned, responsibility for the application transfers to the review process. Further details about the role of the SRA, Chair of the Study Section and other aspects have been described: http://www.csr.nih.gov/events/Bestpractices.htm.