NIH policy on submitting Resubmission applications has evolved since 1996. At that time NIH stopped accepting A3 or higher amendments to an application (see NIH Guide Notices of June 14, 1996 and June 27, 1997) and adopted a policy limiting the number of amendments to two. In 2003, (see NIH Guide Notice of May 7, 2003), the NIH reiterated the policy on the number of amended applications permitted and eliminated the two-year restriction on the receipt of those applications.

The most recent change in policy was announced in October 2008 (see NIH Guide Notice of October 8, 2008 and NIH Guide Notice of November 7, 2008). Beginning with original new applications (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009 due dates and beyond, the NIH will accept only a single amendment (A1) to the original application. It is expected that this revised policy will lead to funding high quality applications earlier, with fewer resubmissions.

Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 second resubmission applications after that date.

Any second amendment (A2) submitted for other than the “grandfathered” applications noted above will be administratively withdrawn and not accepted for review. Applicants who fail to receive funding after two submissions (i.e., the original and the single amendment) may resubmit but only if the application is fundamentally changed to qualify as new. A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in an amended application. Re-wording the title and/or Specific Aims or incorporating changes that are in response to comments in the previous Summary Statement does not constitute a substantial change in scope or content. Changes to the Research Plan should produce a significant change in direction and approach for the research project. Thus, a new application would include substantial changes in all sections of the Research Plan.

Note that there is no time limit for the submission of the A1 amendment of a competing application (see NIH Guide Notice of November 13, 2006). However, a lengthy hiatus after the initial submission may be marked by significant advances in the scientific field and the comments of the reviewers may no longer be relevant. PDs/PIs and their institutions need to exercise their best judgment in determining the advisability of submitting a resubmission application after several years have elapsed.

The revised resubmission policy applies to all NIH extramural applications, including applications submitted under the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, Career Development Awards, Individual Fellowships, Institutional Training Grants, Resource Grants, Program Projects and Centers. NIH does not anticipate making exceptions for any type of application.

No resubmissions are permitted for applications received in response to a Request for Applications (RFA) unless it is specified in the Funding Opportunity Announcement (FOA), in which case only one resubmission will be permitted. Since an RFA often has special considerations of eligibility, scientific scope, and review criteria, unfunded RFA applications must be resubmitted as new applications to another FOA. The new application must be submitted on the scheduled due dates for new applications (see http://grants.nih.gov/grants/funding/submissionschedule.htm).  It must not include an Introduction describing the changes and improvements made; and the text must not be marked to indicate the changes. Similarly, a change of grant activity code (e.g., from an R01 to an R21 or from an R03 to an R01) usually involves a change of eligibility criteria, application characteristics, dollar limits, time limits, or review criteria. These applications also MUST be prepared as new applications. More information on these policies can be found in the NIH Guide Notice of January 16, 2003.

Inquiries

Applicants are strongly encouraged to discuss their questions with their NIH Institute/Center contact.