Questions and Answers for PAR-20-072, NIAID Investigator-Initiated Program Project Applications (P01, Clinical Trial Not Allowed)

NIH published this funding opportunity announcement (FOA) in a September 9, 2022 Guide announcement.

Updated May 28, 2021. NIH posted the “When should I reach out to NIAID staff if I am considering submitting a P01 application?” shown below.

Check the P01 Program Project Grants guide developed by the NIAID Scientific Review Program.

Consultation with a NIAID Scientific/Research Contact listed in Section VII of the FOA is strongly encouraged at least 15 weeks before submission of any P01 application. NIAID staff will then consider whether the proposed program project meets the goals and mission of the Institute and whether it addresses one or more high priority research areas.

If the application will request $500,000 or more for direct costs in any year, applicants must contact the Scientific/Research Contact and obtain approval from NIAID at least six weeks before application submission. This requirement applies even if none of the individual projects requests $500,000 or more. Refer to the NIAID Big Grants SOP.

Use the PHS Assignment Request Form to include information regarding individuals who should not review your application. You may also include scientific areas needed to review your application without including the names of recommended reviewers.  

Yes, see NIAID’s Option to Submit Simultaneously as an R01 Application guidance. If both the P01 and the R01 are fundable, then only the P01 will be funded. You will not have the option to withdraw the project from the multiproject grant.

No, foreign PIs cannot be included in unsolicited P01 applications. Non-U.S.-based scientists can serve as Project or Core Leaders, but not as PD/PI or MPI.

Yes, this is correct. Additionally, as noted in the FOA, all applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan in the Overall section of the application.

Your application will not be reviewed by the Center for Scientific Review, but by a special emphasis panel (SEP) convened by the NIAID Scientific Review Program.

No, the two-day window only applies to applications submitted before the due date. After 5:00 p.m. local time on the application due date, edits cannot be accepted.

See NIH’s policy for Late Applications. The continuous submission policy does not apply to investigator-initiated P01 applications.

Direct your questions to the scientific/research contacts shown in Section VII: Agency Contacts of the FOA.
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