Some Applications Have Deadlines for Actions Before the Due Date

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Thinking about applying for a grant? The due date may not be the only date you need to know. You might also have deadlines for special requirements as many as 15 weeks before your due date.

Big grants, investigator-initiated clinical trials, investigator-initiated program project (P01) grants, investigator-initiated resource-related research projects (R24), and conference grants/cooperative agreements (R13/U13) either require NIAID’s prior approval or prompt you to contact a program officer for prior consultation far in advance of your application due date.

Don’t miss out on the chance to submit your application for your desired due date because you didn’t contact NIAID early enough to obtain the prior approval letter needed for your application’s Cover Letter Attachment or you missed our advice on how to meet these grants’ requirements!

Big Grants

You must get NIAID’s approval for Big Grants—that is, investigator-initiated grant application requests of $500,000 or more in direct costs for any one year. You need to request this approval a minimum of 6 weeks before you submit, but we recommend you contact your program officer as soon as you know your budget is likely to exceed this threshold. Learn more at Big Grants SOP.

This requirement does not apply to applications in response to requests for applications (RFAs) or any notices of funding opportunities (NOFOs) that specify a budget limit above the big grant threshold. In those instances, follow the directions in the NOFO.   

Investigator-Initiated Clinical Trials

If you plan on applying for an investigator-initiated clinical trial (IICT), whether through NIH Research Project Grant (Parent R01, Clinical Trial Required)NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Required)NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required), or NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required), NIAID recommends that you begin consulting with your program officer at least 10 weeks before the application due date. For a large budget request or the Investigator-Initiated Extended Clinical Trial (R01, Clinical Trial Required) you should begin even earlier—touch base with staff 12 weeks before applying. See Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications.

Clinical trials are complicated. The prior consultation allows us to help you optimize your research approach, ensure you meet any unique programmatic requirements, explain additional considerations for setting your milestones and budget, and advise you to apply for the right Activity Code. If you don’t speak with us first, you might not propose a sufficient budget to address our oversight requirements or may not factor in considerations that could prevent you from completing the trial within your proposed project period. Even with a highly meritorious score, NIAID may not be able to make an award if your proposed trial is not an NIAID priority or is not feasible.

And remember that if you are requesting a Big Grant for your clinical trial, you need to get our prior approval; we recommend you do so during the prior consultation process.

Multiproject Research

We strongly encourage you to complete a consultation with NIAID program division staff if you're planning to submit an NIAID Investigator-Initiated Program Project (P01, Clinical Trial Not Allowed) application. Do so at least 15 weeks before the application due date. The program officer will verify that a multiproject approach is suitable to your research.

Additionally, the program officer can provide input as to whether NIAID might be interested in funding the research areas or whether any division-specific requirements might apply to your project. Learning this information early and working with the program officer helps you avoid wasting time on a scheme that NIAID is not interested in funding.

Note that the Big Grants policy applies to multiproject grants if you will request $500,000 or more in direct costs for any year of the overall program, even if none of the individual project requests will exceed $500,000. The deadline to request approval is 6 weeks before the application deadline, though we recommend you do so when completing the recommended prior consultation with NIAID staff 15 weeks before applying.

Conference and Resource Grants

Refer to our Conference Awards SOP if you plan to apply for an NIH Support for Conferences and Scientific Meetings (Parent R13, Clinical Trial Not Allowed) grant. Note that you’ll need to contact NIAID at least six weeks before you submit your application, which in turn allows our staff to verify that, if selected for an award, you will receive funding with sufficient time remaining before the conference takes place.

For the NIAID Resource-Related Research Projects (R24, Clinical Trial Not Allowed) grant, because it is difficult to assess whether a given resource meets NIAID’s criteria for this grant, you are strongly encouraged to consult with NIAID staff 10 weeks before the application due date.

A General Rule for All Applications

Make sure you are registered in eRA Commons and able to log in.

Submit your application sufficiently in advance of a given due date to allow yourself time to detect and resolve technical errors. Such snafus, and how to avoid them, are described in our April 19, 2023 article “Having Technical Difficulties? Here’s How to Meet the Submission Deadline.”

Letter of Intent

Although an optional Letter of Intent is not required, is not binding, and does not factor into the review of a subsequent application, the information it contains will help staff to estimate the potential review workload and plan the review. This better ensures expert, effective, and efficient review of your application.

Send the letter of intent to the peer review contact listed in the NOFO.

In Summary: Help Us Help You

NIAID staff can identify issues that may cause your application to be withdrawn, not fare well in peer review, or have lowered potential for an award. The earlier you contact us, the earlier we can provide advice that you can use to improve your application.

Share the following information with the scientific/research contact listed in the NOFO:

What to Discuss/IncludeWhat We May Spot for You
Concise description of your proposed project. (Do not send us your entire application.)
  • Whether your research would be a good fit for NIAID, and if not, which other NIH institute or center might be more appropriate.
  • Whether your topic seems responsive to the chosen NOFO.
  • If there’s a better funding opportunity for your idea than the one you have in mind.
  • Other concerns worth addressing before you apply.
Whether your plans touch on special policy areas, such as human subjects, clinical, or animal research.
  • Whether your analysis of the NIH definitions or exceptions seems to match.
  • Whether your human subjects research might also be classified as a clinical trial.
  • If there are special rules restricting your choice of animal species or animal-related plans.
  • Other possible limits that could affect your planned avenue of research.
Name of pathogens you plan to study, if any.
  • Whether your research plan fits any opportunity-specific requirements about the type of pathogen—for example, perhaps your choice must be listed as an NIAID Category A, B, or C Priority Pathogen or an Additional Emerging Infectious Disease/Pathogen at NIAID Emerging Infectious Diseases/Pathogens.
Whether the application is foreign or has foreign components.
  • Eligibility to apply.
  • Special requirements regarding budget or other elements that must be addressed in the application.

For more information on how NIAID staff can help you, see Contacting Program Officers and Grants Management Specialists.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

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