March 31, 2023
NOT-OD-23-095 - Expiration of the COVID-19 Public Health Emergency
NOT-OD-23-066 - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: August/October 2023 Councils
NOT-OD-23-006 - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: May 2023 Councils
NOT-OD-22-113 - RESCINDED - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: January 2023 Councils
NOT-OD-22-047 - RESCINDED - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: August/October 2022 Councils
NOT-OD-21-179 - RESCINDED - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: May 2022 Council
NOT-OD-21-095 - RESCINDED - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: January 2022 Council
NOT-OD-20-179 - RESCINDED - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: August/October 2021 Councils
NOT-OD-20-163 - RESCINDED - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic
NOT-OD-20-123 - RESCINDED - Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic
NOT-OD-19-083 - Update to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials
NATIONAL INSTITUTES OF HEALTH (NIH)
In response to the COVID-19 Public Health Emergency, NIH implemented a special exception for post-submission material, allowing a one-page update of preliminary data as post-submission material to specified notices of funding opportunity (NOFOs) (see latest in series of exception notices NOT-OD-23-066). The Public Health Emergency is due to end on May 11, 2023 (see NOT-OD-23-095). For applications submitted for the May 25, 2023 receipt date and beyond, that special exception is ended and is replaced by the following policy.
For applications submitted for the May 25, 2023 receipt date and beyond, NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission material for Type 1 R01, R21, or R03 applications, including resubmissions, if the NOFO used for submission allows preliminary data in the application. Because applications for emergency competitive revisions and urgent competitive revisions undergo expedited review, post-submission materials will not be accepted for those applications.
Scenarios in Which Post-Submission Preliminary Data Are and Are Not Allowed
Mechanism | Type 1 (New and Resubmission of New application) | Type 2 (Renewal) | Type 3 (Competitive Revision) |
R01 | Allowed* | Not allowed | Not allowed |
R21 | Allowed* | Not allowed | Not allowed |
R03 | Allowed* | Not allowed | Not allowed |
All others | Not allowed | Not allowed | Not allowed |
*Only if the NOFO allows preliminary data
The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting, unless specified otherwise in the NOFO.
All other materials listed in NOT-OD-19-083 as acceptable post-submission materials will continue to be accepted if submitted 30 days before the study section meeting. Instructions for submission are included in NOT-OD-19-083.
NIH Review Policy Officer
[email protected]
Francis D. Chesley, Jr., M.D.
Agency for Healthcare Research and Quality
Telephone: 301-427-1521
Email: [email protected]
Steve Dearwent, Ph.D.
Centers for Disease Control and Prevention
Telephone: 404-498-6382
Email: [email protected]
Michael Goldcamp, Ph.D.
Centers for Disease Control and Prevention
Telephone: 304-285-5951
Email: [email protected]