NOT-OD-18-197: NIH/AHRQ Application Submission/Resubmission Policy

NIH/AHRQ Application Submission/Resubmission Policy

Notice Number: NOT-OD-18-197

Key Dates
Release Date: July 23, 2018

Related Announcements

NOT-OD-23-184 - Notice to Rescind NOT-OD-21-027 "Notice of Clarification of SB1 Resubmission/Submission Policy"
NOT-OD-21-027 - Notice of Clarification of SB1 Resubmission/Submission Policy
NOT-OD-15-039 - Simplifying the NIH Policy for Late Application Submission
Rescinded Notices:
NOT-OD-17-042
NOT-96-161
NOT-97-011
NOT-99-146
NOT -OD -03 -019
NOT -OD -03 -041
NOT -OD -03 -065
NOT -OD -09 -003
NOT -OD -09 -016
NOT -OD -09 -100
NOT -OD -10 -080
NOT -OD -10 -135
NOT -OD -14 -074
NOT -OD -14 -082
NOT -OD -15 -059

Issued by
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)

Purpose

Effective immediately, this Notice consolidates and clarifies policy concerning submission and resubmission of applications for grants and cooperative agreements submitted to the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) for funding consideration. In addition, this Notice updates the few situations in which NIH and AHRQ policy allows for changes of activity codes upon resubmission or renewal.

This Notice does not impact the following policies, which are not changed and still apply:

the NIH Late Application Policy (NOT -OD -15 -039),
the NIH Continuous Submission Policy (NOT -OD -17 -042),
the thirty-seven month time limit on A1 resubmission applications (NOT -OD -12 -128and NOT -OD10 -140).

Background

This Notice addresses two related needs. First, this Notice consolidates previous Notices related to application submission. In 2014, the NIH and AHRQ announced a major change in application submission policy, to allow investigators to continue to seek funding for productive research programs without introducing substantial changes to their applications. However, previous Notices had not been rescinded, so some old Notices contained incorrect information.

Second, this Notice explains limited, defined circumstances whereby an application may change activity code at the time of resubmission or renewal. In 2003, NIH announced that applications must be submitted as new when they are submitted to a funding opportunity announcement (FOA) of a different activity code. However, some longstanding NIH programs have evolved over time in a direction better represented by a different activity code, and those changes are explained below.

Policy

Unless noted otherwise, the policy below applies to all types of competing applications (new,renewal, resubmission, and revision) and all types of activity codes, including but not limited to applications for research grants, 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 Center Grants.

Allowable Submissions

Only a single resubmission (A1) of an original application (A0) will be accepted.

If the original A0 application was submitted to a PA, PAR, or PAS program announcement, the A1 application may be submitted to any other PA, PAR, or PAS program announcement that accepts resubmissions, provided eligibility and other requirements are met. Note that the A1 application will be reviewed using the review criteria in the current FOA, not the criteria in the FOA used for the A0 submission.
However, if switching between submission from a PA, PAR, or PAS program announcement to a Request for Applications(RFA), or from an RFA to a PA, PAR, or PAS program announcement, the subsequent submission must be formatted as a New A0 application.

An A0 application may be submitted following an unsuccessful A0 or resubmission A1 application, with the following exceptions:

Only two renewal submissions in a series are allowed the A0 renewal and the A1 resubmission of a renewal. If the A1 resubmission is not funded, no further renewal applications in that series will be accepted. If the A0 renewal application is not funded, the option to submit another A0 renewal application in that series does not exist; the options are to submit an A1 resubmission application or a new (not a renewal) application.
Special considerations apply to SBIR/STTR applications. See the SBIR/STTR Frequently Asked Questions.

NIH and AHRQ encourage applicants to update each subsequent application submission to reflect the status of the field over the interim period and to incorporate new preliminary data, literature citations, letters of reference, etc. as time passes.

An A0 Application (whether new, renewal or revision) that does not conform to the requirements for a New Application will not be reviewed and will not be considered for funding. See Addendum A. There is no administrative requirement that the science in a new A0 application is substantively different from any previously reviewed submission.
Any application overlapping other Public Health Service (PHS) applications that are funded, pending initial peer review (e.g., pending summary statement release), or pending appeal of an earlier review will not be accepted. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. See Addendum B for more details.

Change of Activity Code

A change of activity code(e.g., R01, K01, U01) between the original A0 application and the A1 resubmission, or a funded application and the renewal application, is not allowed, with one exception. Some FOAs will change activity code at the time they are re-issued. In that specific circumstance, the following activity code changes are allowed:

A1 resubmission applications may change activity code when the original A0 application was submitted through a FOA that changed activity code at time of reissuance, and the A1 application is submitted to the reissued FOA.
A0 Renewal applications may change activity code when the application was funded through a FOA that changed activity code at the time of reissuance, and the renewal application is submitted to the reissued FOA.

This exception applies to resubmission applications that were submitted as new or renewal A0 applications to any previous issuances of that FOA and to renewal applications funded through all previous issuances of that FOA. In all other cases, A1 resubmission and renewal applications submitted to FOAs of a different activity code must be submitted as new applications (see Allowable Submissions, above, and Addendum B).
Applications will be withdrawn as noncompliant if they do not conform to this policy.
For more information about this and related policies, see Frequently Asked Questions.

Inquiries

Please direct all inquiries to:

Division of Receipt and Referral
Center for Scientific Review
Telephone: 301-435-0715
Email: [email protected]

Sally A. Amero, Ph.D.
NIH Office of Extramural Research
Email: [email protected]

Lisa Scott-Morring, M.S., M.S.H.S., C.R.A.
Agency for Healthcare Research and Quality
Telephone: 301-427-1555
Email: [email protected]

Addendum A. Compliance with Requirements for New Applications
Whether it follows an unsuccessful application or not, a New Application is neither a ResubmissionApplication nor a RenewalApplication, and must comply with the requirements for a NewApplication.
The following content is NOT allowed anywhere in a New A0 Application or its associated components (e.g., the appendix, letters of support, other attachments):

Introduction page(s) to respond to critiques from a previous review
Mention of previous overall or criterion scores or percentile
Mention of comments made by previous reviewers
Mention of how the application or project has been modified since its last submission
Marks in the application to indicate where the application has been modified since its last submission
Progress Report

This means that:

A New A0 Application submitted after an unfunded New A0 Application or an A1 Resubmission of an A0 Application must be formatted as a New A0 Application and not contain elements of a Resubmission Application (see list above).
A New A0 Application submitted after an unfunded Renewal A0 Application (or after a Renewal Resubmission A1 Application) must be formatted as a New Application and not contain elements of either a Renewal Application or a Resubmission Application (see list above).

Addendum B. Overlapping Applications

Applications are considered to be under review until the summary statement has been issued or an appeal of initial peer review has been resolved (see the NIH appeals policyfor more information). This means that the NIH and AHRQ will not accept:

a New A0 Application that is submitted before issuance of the summary statement or resolution of an appeal from the review of an overlapping New A0 or Resubmission A1 application.
a Resubmission A1 application that is submitted before issuance of the summary statement or resolution of an appeal from the review of the previous New A0 or Renewal A0 application.

The NIH and AHRQ will not review essentially identical applications, except for:

Applications for an Independent Scientist Award (K02) proposing essentially identical research in an application for an individual research project; and
Applications proposing an individual research project identical to a subproject that is part of a multi-project application such as a program project or center grant application.
Applications overlapping with those submitted to organizations or agencies outside the Public Health Service (PHS) (i.e., other than NIH, AHRQ, CDC, FDA, etc). Overlap between applications submitted concurrently to any component of the PHS is not allowed.

Addendum C. Submission of AIDS and AIDS-Related Applications

NIH established (NIH Guide Vol 17 No 9 March 11, 1988) an expedited submission/review/award schedule for AIDS and AIDS -related applications. Such applications have submission dates several months later than non-AIDS applications. If AIDS and AIDS-related applications are submitted on non-AIDS due dates, they will be withdrawn so that NIH complies with the requirement that the interval between submission and funding not be longer than six months. Therefore, submission of an AIDS or AIDS-related application at an earlier date will not result in an earlier review and applicants may wish to take full advantage of the additional time to work on their applications. AIDS and AIDS-related applications may opt out of the expedited review cycle and also be submitted for regular due dates established for all applications. In those cases, a clear indication of this intention in the form of an assignment request to a non-AIDS review group is strongly encouraged.