The policy says there is a two week late window after the due date during which time NIH might accept a late application. How is that late window calculated?

Applications may be accepted within two weeks of the due date, so if the due date is on the 1st of the month, applications could be accepted for two weeks (through the 15th of the month) for funding opportunity announcements that can accommodate late receipt of applications.

If the due date or the end of the late window falls on a holiday, weekend, or NIH Office closure the late window will be adjusted in accordance with our standard submission policies. For example, if the due date is the 1st of the month and falls on a holiday, the new due date will be the 2nd of the month and the late window will run from the 3rd to 16th. Similarly, if the end of the late window is the 15th and falls on a day when Federal offices are closed, the end of the late window would move to the next business day.

I'm a reviewer, can I submit my application late?

Most funding opportunity announcements (FOAs) have a two-week late window of consideration during which time an application can be submitted. However, the terms are very specific, and don’t apply to some Requests for Applications (RFAs). Examples of reasons why late applications might be accepted include Review Service, Illness, Natural Disasters etc. However, no advance permissions can be given for late applications. You should list your reasons in the cover letter with your application and the decision will be made on a case-by-case basis. You should read the NIH late policy in the NIH Guide Notice NOT-OD-15-039 for an explanation of how the policy may apply to you. In addition, some reviewers have continuous submission eligibility because they are appointed to an NIH review group such as a study section or institute advisory council or have “recent substantial service.” Under continuous submission, these reviewers may submit R01, R21, and R34 applications with standard due dates at any time during the council round. Read the NIH continuous submission policy in both NOT-OD-17-042 and NOT-OD-18-178 if this policy applies to you.

Can I get approval in advance from NIH to submit my application late?

No. Permission to submit late is not granted in advance. If an application is submitted late, a cover letter explaining the reasons for the delay must be included with the signed, submitted application. The information included in the cover letter will be used to evaluate application acceptance on a case-by-case basis.

Note: Cover letters are maintained separately from the assembled application image and are only made available to a small subset of staff, mainly receipt and referral and review staff. Reviewers are never given access to cover letter information.

What is allowed in the Appendix?

For applications submitted to due dates on or after January 25, 2018: Only the items listed in NOT-OD-17-098, plus any additional items if specifically listed in the individual funding opportunity announcement as required or optional.

What are some examples of things not allowed in the appendix?

If it is not specifically listed as allowed in the Notices or in FOA used to submit the application, it is not allowed.

However, for purposes of clarity, a few examples of unallowable appendix items include but are not limited to:

  • Methods or instructions for conducting the research
  • Methods or instructions for analyzing the data
  • Manuals
  • Clinical trial protocols, or protocol synopses, in applications that do not propose to conduct a clinical trial
  • Investigator’s Brochure section from an FDA IND application in applications that do not propose to conduct a clinical trial.
  • Lists of abbreviations, definitions, or codes
  • Data or other information, either preliminary or published, including tables, charts, graphs, figures, diagrams, graphics, images, screen shots, etc.
  • Powerpoint presentations
  • Papers, posters, or abstracts, including those in preparation, submitted, accepted for publication, or posted as pre-prints
  • Reports, including market survey reports, and summaries of reports or sample reports
  • Patents, patent applications, or materials intended for a patent application
  • Hyperlinks
  • Videos
  • Flyers, curricula, course descriptions
  • Case studies
  • Files containing a mixture of allowed and unallowable Appendix materials
  • Items that appear to be “similar to” one of the allowed Appendix items
  • Items specified in the FOA as not allowed in the Appendix

This is not intended to be a definitive list of unallowed materials; these examples are provided for purposes of clarity.

The instructions for appendix materials in the funding opportunity announcement do not match the instructions for appendix materials in NOT-OD-17-098 or the NIH Application Guide. Which one do I follow?

Instructions in the funding opportunity announcement for additions to or further restrictions on the types or amounts of materials allowed in an Appendix supersede other general NIH instructions for Appendix materials.

What is the current policy on resubmissions?

Only a single resubmission (A1) of an original application (A0) will be accepted. Following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-18-197 for exceptions).

Resubmissions (A1) must be submitted within 37 months of the new (A0) application (see NOT-OD-10-140 and NOT-OD-12-128).

For more details on the Resubmission Policy, visit the Resubmissions webpage and see NOT-OD-18-197.

Must I wait for my summary statement before submitting my idea again?

Once your application has been reviewed, you must wait for the summary statement to be issued before you resubmit that application or submit any other application with substantial scientific overlap.

Is there a limit to the number of times an application may be submitted as new?

No. The number of such cycles is not limited, but NIH encourages applicants to update their applications 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.

Is there a benefit to submitting a resubmission rather than a new application?

A resubmission allows you to provide a one page introduction, to tell reviewers directly how you have addressed their critiques. Alternatively, the introduction allows you to explain why you did not address them.

My application was not discussed. Should I develop a new application or try to address the reviewers’ comments in a Resubmission application?

This issue should be considered on a case-by-case basis. Read the summary statement carefully and note weaknesses that you could address in a reasonable length of time. Discuss the critiques with your collaborators, colleagues, and/or senior researchers/mentors to get their suggestions. The PO also can discuss your options going forward. It is possible for an application that carefully addresses the reviewers’ comments to go from being “not-discussed” to receiving outstanding scores upon resubmission.

Am I allowed to submit the same application as a new and a resubmission application in the same Council round?

Generally, no. NIH will not allow duplicate or highly overlapping applications to be under review at the same time. This includes: 1) a new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application; and 2) a resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. (NOT-OD-18-197)

My resubmission application was not funded. May I now submit it as a new application?

Yes. Investigators should take into account the scores of the previous application, the reviewer comments, and any advice from NIH program staff when deciding whether to submit the application as new. Should you decide to submit the application as new, take advantage of the comments from reviewers to reshape your application, but remember, you should not directly reference the previous review in the new application. If the previous application was a renewal resubmission, the new application should not include a Progress Report or a Progress Report Publication List. (Note special rules apply for submitting after an unsuccessful Phase II SBIR/STTR application.) Work from the prior funding period should be presented as preliminary data and/or rationale for the proposed research. Publications from the prior work may be cited in the reference list, as applicable, and/or listed in the biosketches of the investigators.

Can I submit the same application to two different FOAs simultaneously?

In most cases, two or more applications that have scientific overlap in the experiments proposed are not allowed in peer review at the same time, even if one is to an RFA and the other(s) to a PA/PAR/PAS. There are exceptions to this rule. NIH allows subprojects of Program Project Grant applications to be submitted as research applications (R01, R03, R15, R21, etc.) in the same cycle. In most cases, a second application for the same project should not be submitted until after the summary statement for the original submission has been released. See more information on overlapping applications.

Can an additional PD/PI be added or removed before submitting a Resubmission application?

A PD/PI can be added to or removed from the resubmission application. It is best to explain these changes in the introduction of your application. A change of PD/PI also needs to be noted via a checkbox in the application.

How are resubmission applications reviewed?

Reviewers are instructed to evaluate the resubmission application as presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. For resubmitted renewals, the committee will also consider the progress made in the last funding period.

May I request that my Resubmission application be reviewed by a different study section or have primary assignment to a different NIH IC than my original application?

Resubmission applications usually are assigned to the same study section and Institute/Center (IC) as the original application but you can request a change using the Assignment Request Form with the resubmission application following the instructions in the SF424 (R&R) Application Guide. It is a good idea to consult with your Program Officer (PO) and/or Scientific Review Officer (SRO) to discuss whether a change would be appropriate.

The Division of Receipt and Referral (DRR) at the Center for Scientific Review (CSR) is responsible for assigning applications to ICs and in some cases to Scientific Review Groups (SRGs). DRR usually accommodates requests if appropriately justified and requested well before the review meeting date, but reserves the right to make the final decision. ICs websites describe mission interest which can help applicants match topics of research to the appropriate funding component. The CSR website provides information regarding the focus of expertise of each of the CSR standing study sections.

You may direct referral questions to the CSR Referral Office (CSRDRR@mail.nih.gov or 301-435-0715).

What should I do if I do not agree with my review group assignment or IC assignment?

Contact the NIH scientific review officer assigned to your application to discuss the review assignment. While the SRO can look into the concern and describe the panel’s expertise, in CSR the Integrated Review Group Chief and in IC’s the Review Branch Chief has the authority to make assignment changes and should become involved when it is clear that a change is desired by the applicant.(This statement is from CSR) Contact the Division of Receipt and Referral in the Center of Scientific Review to discuss the IC assignment (CSRDRR@mail.nih.gov or 301-435-0715)

Are reviewers allowed to consider previous submissions when reviewing applications submitted as new?

No. The scientific review officer will remind reviewers that they must only consider the information included in the new application.

Can I resubmit or submit my application as new while my application is under appeal of the initial peer review?

No. The appeal must be resolved in order for you to submit that application again.

Do I need to contact the Program Officer before I submit a new R01 application? How early should this happen? Should I send a summary of the grant?

It is a good idea to contact a Program Officer (PO) to discuss if the PO’s NIH funding Institute is interested in the proposed project. The earlier this is done the better and one should discuss with the PO what they prefer i.e. to receive a summary of the grant, just specific aims or to have a discussion on the phone.

Whom should I contact, if after multiple attempts I cannot get a response from the Program Officer?

If you cannot reach the program officer after several attempts, you can reach out to the Scientific Review Officer (SRO) who may be able to direct you to an additional person in the Program Officer’s office for you to talk to. Email is usually more efficient than phone calls. Please note that the SRO cannot provide scientific guidance about your grant application.

Is it better to appeal a review or to just resubmit a new application?

The NIH is very specific about the circumstances when one can appeal a review. You may appeal the review process if there is evidence of bias or conflict of interest on the part of one or more of the reviewers; lack of appropriate expertise within the study section; and/or factual error(s) made by one or more of the reviewers that could have altered the outcome of the review substantially. A difference in scientific opinion(s) is NOT grounds for appeal. You may wish to talk to your Program Officer (PO) to get advice about appealing, resubmitting or submitting a new application. The PO can explain the appeal process to you, tell you their experience with situations like yours and give you an idea of what you may wish to do next.

How do I withdraw my application?

The signing official at your institution can now request withdrawal of an application directly through eRA Commons. See NIH Guide Notice NOT-OD-16-143 for instructions. Alternatively, a letter with ink signature from your signing official can be sent to csrdrr@mail.nih.gov and we will process your request manually.

How can I find a Program Officer or Scientific Review Officer to answer questions before submitting my application?

Before you submit your application, Program Officers or POs can identify the right type of grant program and/or funding opportunity for you and your research and verify that your idea fits within the mission and priorities of an NIH Institute or Center. POs also can refer you to appropriate scientific review officers or study sections.

To find a PO or an NIH Institute or Center that might fund your research, go to the Matchmaker tool in NIH’s RePORTER database and click on the find-program-officials tab.

If you wish to find a scientific reviewer officer or study section at CSR, you can search study section descriptions or use the Assisted Referral Tool on CSR’s home page: www.csr.nih.gov

After you submit your application, your assigned program officer and scientific review officer will be listed in your eRA Commons account.

For more guidance, visit the Contact NIH Staff page.