Notice Number: NOT-OD-10-080

Update: The following update relating to this announcement has been issued:

• April 15, 2011 - See Notice NOT-OD-11-064 Appeals of NIH Initial Peer Review.
• October 1, 2010 - See Notice NOT-OD-10-140 This Notice announces the implementation of a new time limit between the submission of a New, Renewal, or Revision1 application and a Resubmission (A1 version) of that application to the National Institutes of Health (NIH).
• September 9, 2010 - See Notice NOT-OD-10-135 This notice serves as a reminder that the final opportunity to submit second resubmission (A2) applications (when the original application was assigned to Council Meetings of August 2009 or earlier) is approaching.

Key Dates
Release Date:  April 15, 2010

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

This notice clarifies the existing resubmission policy as announced in NOT-OD-09-016 and NOT-OD-09-003, which collectively stated that applications submitted for due dates before January 25, 2009 are allowed two resubmissions (A1 and A2), and applications submitted for due dates on or after January 25, 2009 are allowed only one resubmission  (A1).  The resubmission policy applies to all types of applications, every activity code, and applications submitted in response to Program Announcements (PA, PAR, PAS) or Requests for Applications (RFA).

Clarification of Resubmission Policy

January 25, 2009 was chosen as the cut-off date because it is the first standing due date for applications to be considered for Fiscal Year 2010 funding (Cycle I/October 2009 Council).  In the Enhancing Peer Review process, NIH has generally coordinated significant changes with the start of a new fiscal year.  However, the situation for some applications submitted under the continuous submission option, requires further clarification to permit investigators to accurately determine their resubmission options. 
This notice clarifies that the determination of whether an application is allowed one or two resubmissions ultimately depends upon the fiscal year of funding and the assigned council date.  Applicants can determine the assigned council date for each application by examining the first page of the Summary Statement, or by viewing the Status page in eRA Commons. 

Determination of eligibility to submit A2 resubmissions

• All applicants (including those who were eligible for continuous submission) who submitted A0 applications that were assigned up through August 2009  council are permitted two resubmissions. 
• All applicants (including those who were eligible for continuous submission) who submitted A0 applications that were assigned to October 2009 council or later are permitted only one resubmission. 

Determination of last opportunity to submit A2 resubmissions

• Applicants who are allowed to submit two resubmissions for their “grandfathered” A0 application must submit their A2 application no later than the appropriate due date for cycle III
• September 25, 2010 for Program Projects and Centers, T series, R25, SC1, SC2, SC3, and other activity codes
• October 25, 2010 for R15 applications
• November 5, 2010 for R01 and U01 applications;
• November 12, 2010 for career development applications;
• November 16, 2010 for R03 and R21 applications;
• December 5, 2010 for small business applications;
• December 8, 2010 for fellowship applications;
• December 12, 2010 for conference applications
• January 7, 2011 for  all AIDS applications;
• Applicants who are currently eligible for continuous submission for R01, R21, and R34 applications, and who are allowed to submit two resubmissions for their “grandfathered” A0 application that is not on AIDS-related research, must successfully submit the A2 application by December 16, 2010.
• Applicants who are currently eligible for continuous submission for R01, R21, and R34 applications, and who are allowed to submit two resubmissions for their “grandfathered” A0 application on AIDS-related research, must successfully submit the A2 application by February 7, 2011.  

NIH action when an invalid A2 application is received

If an applicant submits an A2 application for which only one resubmission is allowed, the A2 application will be administratively withdrawn by the Center for Scientific Review (CSR) Division of Receipt and Referral and the Program Director/Principal Investigator and applicant institution will be notified.

Determination of New Application Status

A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in a resubmitted application. A new application should include substantial changes in all sections of the Research Plan, particularly in the Specific Aims and the Research Strategy sections. There should be fundamental changes in the questions being asked and/or the outcomes examined. Changes to the Research Plan should produce a significant change in direction and approach for the research project. In the case of institutional Training and institutional Career Development applications, there must be a significant or substantial change in the programmatic, leadership, administrative, or other critical aspect of the program.  Rewording of the Title and Specific Aims or incorporating minor changes in response to comments of reviewers in the most recent Summary Statement does not constitute substantial changes in scope, direction or content. Requests for review by a different review committee or funding consideration by a different NIH Institute are not sufficient reasons to consider an application as new. Submission to a different FOA is also not sufficient to make an application new (there are exceptions for applications following an RFA or changing activity code; see NOT-OD-09-100). 

Applications received by the NIH are screened multiple times and checked to determine if the application is a new application, not simply another version of a project that has already received the maximum number of reviews. The first check is done within the CSR Division of Receipt and Referral. Subsequent checks are performed by the Scientific Review Officer (SRO) in charge of the review meeting and by NIH program staff.  

Within CSR staff may refer it to a CSR-convened committee that provides further analysis and recommendations to the Division of Receipt and Referral. The evaluation process includes the analysis of previous applications and summary statements to determine the similarities to and differences from the current application. Other Institutes and Centers have their own evaluation processes. When applications are determined to be in violation of the resubmission policy, they are administratively withdrawn and are not reviewed. The CSR Division of Receipt and Referral informs the Program Director/Principal Investigator and institution of this determination.  

Inquiries

For additional information or questions, please contact:

Division of Receipt and Referral
Center for Scientific Review
6701 Rockledge Drive MSC 7720
Bethesda, MD 20892-7720 
Voice: (301) 435-0715
Fax: (301) 480-1987

Or send an email to EnhancingPeerReview@mail.nih.gov. For more information on NIH’s Enhancing Peer Review effort, visit http://enhancing-peer-review.nih.gov/. 

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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