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Submission and Assignment Process

The receipt and referral process is an important aspect of the overall NIH peer review system. 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 consult with Institutes/Centers, Scientific Review Officers (SROs) and Integrated Review Group (IRG) Chiefs, and applicants to reach the most 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 NIH is completing a transition from a paper to electronic submission process via Grants.gov. This is also accompanied by a switch to the SF 424 family of forms. While these efforts are resulting in many changes in the logistics of submission, they are not changing the fundamental practices and philosophy of the submission and assignment processes. Up to date information on the electronic submission process is found on the NIH Electronic Submission Web site.
 
Noncompeting progress reports are not sent to CSR or submitted through Grants.gov but are submitted using the PHS 2590 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.
 
Investigators are encouraged to include a cover letter (for electronic submissions this is a PDF attachment) with their application. Use of the structured format described in the application instructions will aid in the use of knowledge management approaches for assignments. The cover letter may address one or more of the following points:

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. For multidisciplinary applications it is very helpful for the investigator to highlight 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 our Review Group Descriptions Web page as a source of information for applicants. Applicants may wish to contact SROs or the DRR (301-435-0715) with specific questions about a potential assignment.
 
· Other important information about the application, such as eligibility for continuous submission or the reason for a late submission.
 
For paper submissions 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.
Permission is not given in advance for a late submission. For standard due dates NIH has established a window of consideration in which applications must be received in order to have a possibility of acceptance. All late applications (paper and electronic submission) must include a cover letter that provides details on the specific reasons for the delay. Further information is found in the NIH Late Application Policy. A special opportunity for continuous submission of R01, R21, and R34 applications is available for appointed members of NIH study sections and advisory groups and reviewers with recent substantial service.
 
Applicants should make sure that applications are complete and have the correct version of all text. The NIH policy on post submission materials limits the materials that may be accepted after submission; this does not include missing pages or corrected pages.
 
Checking the Application for Compliance with NIH Policies
In the initial processing of applications submitted in paper format data items from the face page, budget pages, and checklist are entered into a database to create a unique record for each application. The current version of the application instructions must be used.
 
For electronic submissions the Funding Opportunity Announcement (FOA) determines the validations that will be applied in processing the application. The data elements entered will be directly transferred to the NIH IMPAC database. If errors are identified in the validation process, the errors must be addressed and a changed/corrected application resubmitted to Grants.gov. Applicants are encouraged to start the submission process early enough to allow for error correction and still have an error free on-time submission by 5 p.m. local time on the due date.
 
Processing and assignment of applications in the DRR includes checking for compliance with important NIH policies. Among the policy issues addressed for paper and electronic submissions in the DRR are the following.
 
· The application must be complete and must contain sufficient information for the review group to evaluate the scientific and technical merit of the application.
 
· Submissions of similar, essentially identical, or identical applications to one or more components of the PHS are not allowed.
 
· Resubmission applications cannot be submitted until the Summary Statement from the previous review is posted in eRA Commons. Resubmission applications must include an Introduction that discusses the previous review, and the text should be marked to show where changes have been made. NIH limits the number of resubmission applications to one (A1) which must be submitted within 37 Months of the original application.
 
· 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 resubmission.
 
 
· Approval is needed for applications requesting $500,000 or more in direct costs: NIH policy requires that any competing application (new, renewal, resubmission, revision) requesting $500,000 or more in direct costs in any year must be accepted by an Institute or Center prior to assignment for review. Investigators need to contact the Institute or Center at least six weeks prior to the submission of the application. Note that any Facilities and Administrative costs of subcontracts are not included.
 
 
· 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 NIH registry will be used.
 
· 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 instructions. This applies to paper submissions and the PDF attachments of electronic submissions. Noncompliant applications may be withdrawn from the review and funding consideration process. .
· An eRA Commons User Name must be provided for all Principal Investigators for all applications (paper and electronic).
 
· At least three reference letters are required for fellowship applications (predoctoral, postdoctoral, and senior fellowships) and mentored research career development award applications by the application due date.
 
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 staff have access to the entire application, not just the title and Abstract/Description. In many cases, they concentrate on the Abstract/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 and how to handle unusual situations. The assignment of a grant application involves a series of decisions.
 
· Determination of activity code. There are more than 100 activity codes to support research and research training ranging from individual fellowships through very large center grants. Nearly all Institutes and Centers (ICs) use the R01 and F32; a single or only a few ICs use other activity codes. The correct Funding Opportunity Announcement is critical for determination of the activity code. Activity Codes are identified in the NIH system by a letter and number code; examples include the following:
F32 Individual NRSA Postdoctoral Fellowship
K08 Mentored Clinical Scientist Research Career Development Award
P01 Program Project
R01 Research Grant
R43 Small Business Innovation Research Phase I (R44 for Phase II)
More information is available via the NIH Grants Web page.
 
· An Institute or Center (IC) 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. Assignments are limited to the Institutes/Centers that participate in the specific FOA used for application submission.
 
· Applications may also receive dual IC 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 have access to 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, 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.
 
For applications to be reviewed by 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 an IC standing committees or by an IC Special Emphasis Panel.
 
For applications to be reviewed 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 SROs 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 SROs 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 SROs 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.
The following Information about the assignment (review and Institute/Center) is accessed through the eRA Commons.
· The assignment number which is in the format 1 R01 CA987654-01 and provides the following information:
o The type
1 new application
2 renewal application
3 revision application
 
o The activity code (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- "987654"
 
o The year and any suffix (01 is year 1, A1 indicates the first resubmission, S is used for revision)
 
· 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 Officer (SRO). The SRO 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.
 
If this information is not available in the Commons within two weeks organizations you should promptly contact the Division of Receipt and Referral (301-435-0715; 301-480-1987, fax).
 
If there are questions about the correctness and appropriateness of the assignment, the investigator should contact the SRO 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. When the review location, primary institute, or timetable for consideration (council round) is changed for an application, the information will be updated in the Commons.
 
Once the application has been assigned, responsibility for the application transfers to the review process. For additional information, go to CSR’s Peer Review Meeting Web page.


July 2011